Sökresultat för "quality management system"

Build the systems behind Circular IT. Help shape how quality, safety and continuous improvement come to life at Foxway. At Foxway, we're transforming the way organizations buy, use and reuse technology. As a leading provider of Circular IT solutions, we help businesses reduce costs, lower environmental impact, and extend the lifecycle of their devices. We're now looking for a Quality Manager to join our CWS (Circular Workspace Solutions) organization. If you're passionate about management systems, operational excellence, and creating practical improvements that make a real difference, we'd love to hear from you. About the role As our Quality Manager, you'll play a central role in strengthening how we work across CWS. You'll be responsible for developing and maintaining our Integrated Management System while ensuring our operations continue to meet ISO standards and regulatory requirements. But this role goes beyond compliance. You'll work closely with Operations, Leadership, and Group Compliance to identify improvement opportunities, strengthen processes, and help build a culture where quality, safety and continuous improvement are part of everyday work. This is a hands-on role where you'll balance governance with practical implementation—translating requirements into processes that genuinely support the business. In this role, you will: Own and continuously develop the CWS Integrated Management System (IMS). Ensure compliance with ISO 9001, ISO 14001, ISO 45001 and ISO 27001. Plan and conduct internal audits while supporting external certification audits. Drive continuous improvement initiatives together with Operations and business leaders. Facilitate risk assessments, supplier evaluations and non-conformity management. Develop practical processes, routines and documentation that support daily operations. Deliver training and increase awareness around quality, compliance and management systems. Collaborate closely with Group Compliance and cross-functional stakeholders across Foxway. This role requires on-site presence at least four (4) days per week and is based primarily in Växjö, where you'll work closely with our operational team. Occasional travel between Foxway locations is expected to enable close collaboration with operations and stakeholders. We believe you have Around five (5) years or more of relevant experience within Quality Management, Integrated Management Systems, Compliance, Operational Excellence, or similar fields. Practical experience working with ISO management systems, particularly ISO 9001, ISO 14001, ISO 45001 and ideally ISO 27001. Experience conducting internal audits and supporting certification processes. A background from operations, manufacturing, logistics, warehouse or other operational environments where quality systems play a key role. Proven experience driving continuous improvement and implementing process changes across an organization. The ability to initiate, drive and follow up improvement activities from idea through implementation. Experience facilitating workshops, analysing business needs, and translating them into practical processes and solutions. Fluency in AI-powered and IT tools to improve processes, documentation, and ways of working. Strong communication and stakeholder management skills with the ability to influence across different functions. A structured, pragmatic and solution-oriented way of working. Fluency in Swedish and English is required. Norwegian fluency is a merit. To thrive and succeed with us... Curious. Passionate. Committed. Courageous. These four values guide everything we do at Foxway, and we're looking for someone who shares them. You have a hands-on mindset—you don't wait for perfect input but proactively develop proposals, documentation and ways of working together with process owners. You're someone who enjoys turning complexity into practical solutions. Rather than maintaining processes for the sake of documentation, you're motivated by making them work better for the people using them every day. You build trust across the organization. You communicate confidently with different stakeholders, and know how to influence without relying on formal authority. You turn improvement into action. You're equally comfortable facilitating audits, leading workshops, or working alongside Operations to identify practical improvements. Proactive and collaborative, you're driven by finding better ways to strengthen quality, efficiency, and the overall customer experience. Most importantly, you want your work to contribute to a more sustainable and circular way of managing technology. Why join Foxway? Help shape how quality and continuous improvement evolve across our CWS business. Play a key role in maintaining and developing management systems that support our long-term growth. Work closely with operational teams where your ideas and improvements make a visible impact. Grow your career in an international, collaborative environment where initiative and development are encouraged. Help us make a difference We are reviewing applications on an ongoing basis, so if this sounds like the next step in your career, apply now and submit your application in English. Summer recruitment notice As many of us will be enjoying a well-deserved summer break, our recruitment process may take a little longer than usual during July-August. We look forward to getting back to you once we’re officially back! For the selected final candidate Foxway will conduct a background check as part of our recruitment process, in accordance with applicable local legislation and our internal screening policy. The scope of the check depends on the position and the country in which it is based. You will be informed of the details, and your approval will be requested before any check is initiated. How does Foxway operate? Foxway is a fast-growing and dynamic organization with an international team of nearly 1,300 people. We operate across multiple countries, with key hubs across Europe. Within Foxway, Circular Workspace Solutions (CWS) focuses on delivering sustainable workplace solutions through Device-as-a-Service, lifecycle services, and IT Asset Disposition offerings for enterprise and public sector customers. Our mission is to make sustainable technology accessible to everyone by extending the life of IT equipment and enabling circular business models. By joining us, you become part of a purpose-driven, international team that is shaping the future of sustainable workplaces and circular technology.

The Opportunity As our new Senior Quality Assurance Specialist, you will be responsible for strengthening quality management methods, processes, and systems across the factory. The role focuses on proactive quality management, process standardization, risk-based thinking, and reduction of recurring issues and Cost of Poor Quality, in line with ISO 9001 and PGHV requirements. This role owns and develops Quality Management Methods within the factory, ensuring a robust and effective QMS/IMS. How You’ll Make an Impact Own, maintain, and continuously improve the local Quality Management System (QMS/IMS) in line with ISO 9001 and BU requirements Define, standardize and improve quality-related processes and cross-functional interfaces across the factory Drive proactive quality management through risk assessments, preventive actions, and systematic process reviews Lead root cause analysis for recurring and cross-functional quality issues and ensure effective preventive measures Plan, perform, and coordinate internal audits, and support external audits including follow-up of corrective actions Analyze quality performance and Cost of Poor Quality trends to identify systemic improvement opportunities Your Background Bachelor’s degree in Engineering, Quality, Manufacturing, or equivalent Quality-related training or certification is an advantage (ISO 9001, Internal Auditor, L6S, etc.) Knowledge in Quality Management Systems (ISO 9001), Process mapping and documentation (ADONIS or similar), Root Cause Analysis (8D, 5 Why, Ishikawa) and Internal auditing Experience from Continuous Improvement methodologies (Lean, Six Sigma, HCCO, etc.) You have a Risk-based and preventive mindset and are strong when it comes to Cross-functional collaboration and facilitation Fluency in English is required. Swedish is an advantage, but not mandatory. What We Offer Collective agreement and flexible working hours. Health care and wellness allowance. Career opportunities within Hitachi Energy, locally and globally. Mentor support during onboarding. Training and development programs. A diverse workplace with 70+ nationalities in Sweden. Supplementary parental leave compensation. Access to an Employee Benefit Portal with discounts. More About Us At Hitachi Energy, you’ll work in an exciting, collaborative environment delivering world-class technology. We value personal development and diversity, and we are committed to building a sustainable energy future. We are growing and welcome applicants who may not meet every requirement—your potential matters. Applications are reviewed on an ongoing basis, so don’t wait—apply today! For questions about the position, contact Recruiting Manager Ahmed Abujamea at ahmed.abujamea@hitachienergy.com. Union representatives: Sveriges Ingenjörer: Philip Bengtsson +46 107-38 25 17, Unionen: Michael Fosselius +46 107-38 46 19. All other questions can be directed to Talent Partner Michael Blomberg, michael.blomberg@hitachienergy.com

The opportunity We are looking for a Quality Specialist or Quality Engineer to join GI MACH in Sweden. MACH is a modular advanced control system for control and protection functions. MACH have approximately 500 employees developing electronics hardware and software. You will be a part of a small team responsible for Quality assurance, Process Governance and Product Reliability, which support the MACH organization with specialist competence within Quality. You have a solid background within Quality and knowledge from project management. You will in close cooperation with hardware and software engineers, create good practices and streamline the proactive quality process within R&D. It is an advantage if you have additional experience from software quality processes. If you want to take the next step in your career and contribute to develop a stronger, smarter, and greener energy system, then join us now! We are interested to learn more about you and what you can contribute so don’t hesitate to apply even if you don’t meet all the requirements. How you’ll make an impact Supporting the organization in driving improvement activities preventing quality issues Proactively evaluate and develop quality processes, measure quality activities, review and coordinate quality assurance activities Process governance and follow up of process adherence Promoter of a positive and proactive quality culture within MACH Continuous improvement driver to enhance development and product quality Perform internal audits and support in external audits Quality support and assurance of product development following Gate Model Your background Quality background is required – preferable within R&D. Engineer degree is not required if you have equal work experience within quality and R&D Demonstrated knowledge within Processes and management systems based on process methods Demonstrated knowledge of quality assurance and continuous improvement methods & approaches Six Sigma Yellow belt or 8D, DMAIC, PDCA skills Communication skills, ability to build trust on all levels of the organization Skills in MS Office and common quality management software Adonis process tool knowledge is meritorious Software or electronics background is meritorious Internal auditor and ISO 9001 background is meritorious Knowledge within FMEA methods and standards is meritorious More about us We offer you the opportunity to work with fantastic people and develop yourself on projects that present great technical challenges and have a real impact. Recruiting Manager Esbjorn Johansson, esbjorn.johansson@hitachienergy.com will answer your questions about the position. Union representatives - Sveriges Ingenjörer: Mikael Hjort, +46 107-38 29 86; Unionen: Fredrik Holmgren, +46 107-38 21 85; Ledarna: Frank Hollstedt, +46 107-38 70 43.

Quality Inspector Job brief We’re currently seeking experienced Quality Inspectors to join our team. In this role, you will be responsible for ensuring the quality of the project contractors and their provided products and services. You will collaborate with cross-functional teams to review contractors’ documentation, address quality issues, drive continuous improvement, and contribute to build high-quality products. The ideal candidate will possess a strong background in quality assurance and quality control, exceptional attention to detail, and a proactive mindset. If you are passionate about quality and delivering excellence, we encourage you to apply and become a valued member of our team. Responsibilities Review quality plans, ensuring products or services meet the established quality standards and requirements. Review contractor’s quality documentation: ITPs, procedures, quality reports, manufacturing record books, etc. Participation on audits based on ISO 9001:2015 requirements. Update the project Quality Management System (QMS) with non-conformities and improvements. Collect and review quality metrics. Coordinate inspections. Prepare reports on malfunctions and corrective actions. Coordinate with external quality assurance auditors and Notified Bodies and ensure legal compliance. Requirements and skills At least 3 years of work experience as a Quality Inspector in industrial projects. Experience with contractors providing civil works, structural steel, piping installation and/or electrical and mechanical work. In-depth understanding of technical documentation. Experience with Quality Management Systems (QMS) and testing methods. Great attention to detail and problem-solving abilities. Team spirit and good analytical skills. Experience in EPC/EPCM/PMC projects. Any additional certification in Quality Assurance, Welding Inspection, Non Destructive Examination, etc., is a plus. Fluent in English.

We’re currently seeking experienced Quality Inspectors to join our team. In this role, you will be responsible for ensuring the quality of the project contractors and their provided products and services. You will collaborate with cross-functional teams to review contractors’ documentation, address quality issues, drive continuous improvement, and contribute to build high-quality products. The ideal candidate will possess a strong background in quality assurance and quality control, exceptional attention to detail, and a proactive mindset. If you are passionate about quality and delivering excellence, we encourage you to apply and become a valued member of our team. Responsibilities Review quality plans, ensuring products or services meet the established quality standards and requirements. Review contractor’s quality documentation: ITPs, procedures, quality reports, manufacturing record books, etc. Participation on audits based on ISO 9001:2015 requirements. Update the project Quality Management System (QMS) with non-conformities and improvements. Collect and review quality metrics. Coordinate inspections. Prepare reports on malfunctions and corrective actions. Coordinate with external quality assurance auditors and Notified Bodies and ensure legal compliance. Requirements and skills At least 3 years of work experience as a Quality Inspector in industrial projects. Experience with contractors providing civil works, structural steel, piping installation and/or electrical and mechanical work. In-depth understanding of technical documentation. Experience with Quality Management Systems (QMS) and testing methods. Great attention to detail and problem-solving abilities. Team spirit and good analytical skills. Experience in EPC/EPCM/PMC projects. Any additional certification in Quality Assurance, Welding Inspection, Non Destructive Examination, etc., is a plus. Fluent in English.

Quality Engineer About the Job TUSA Energi AB is expanding its project organization for a major industrial construction and installation project. We are now recruiting an experienced Quality Engineer to support quality assurance and quality control activities at our project site in Boden, Sweden. Work Duties Implement and maintain the project's Quality Management System (QMS) Ensure compliance with project specifications, applicable standards, and client requirements Prepare, review, and maintain quality documentation, including Inspection and Test Plans (ITPs), procedures, and quality records Perform inspections and coordinate quality control activities during construction and installation Monitor subcontractor and supplier quality performance Coordinate inspections with clients, consultants, and third-party inspectors Manage non-conformance reports (NCRs), corrective actions, and preventive actions Support internal and external quality audits Maintain quality reports and project documentation Promote continuous improvement and ensure compliance with Swedish workplace safety and quality regulations Qualifications Experience as a Quality Engineer, QA/QC Engineer, or similar role in industrial, construction, or energy projects Good knowledge of quality management systems and inspection procedures Experience with quality documentation, inspections, and reporting Familiarity with ISO 9001 and applicable international quality standards is an advantage Ability to work independently and collaboratively within multidisciplinary teams Strong organizational and communication skills Turkish and/or Swedish are considered strong advantages Employment Conditions & Benefits Full-time employment: 40 hours per week Saturday work may be required depending on project needs Overtime is compensated according to Swedish labor law and applicable agreements Camp accommodation provided: private room with bathroom and kitchen access Three meals per day provided by employer Internal transport between camp and worksite included Employment follows all applicable Swedish labor laws, including work environment and safety regulations Mandatory workplace insurances according to Swedish requirements Personal protective equipment (PPE) provided where applicable ID06 registration arranged and paid by employer Mandatory safety training included Salary is offered at a competitive market level for this type of Quality Engineer role. All required workplace insurances are included and aligned with Swedish industry standards and union-based protections for comparable positions. Workplace Project site located in Boden. How to Apply Send your CV and relevant certificates to: info@tusaenergi.se Öppen för alla Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov.

Nanexa is now recruiting a Quality Assurance (QA) Manager. The position is full-time and based at our headquarters in Uppsala, and we are looking for a new colleague to join our growing organisation. As a QA Manager at Nanexa, you will play a key role in building and shaping the quality function in a growing pharmaceutical company. This is not a traditional QA role in a large organisation – instead, you will be part of a small, highly skilled team where your contributions will have a direct and visible impact on how we work and grow. You will have the opportunity to develop, implement and continuously improve our Quality Management System while being actively involved in the full product lifecycle – from early development to manufacturing of clinical trial material. The role combines strategic responsibility with hands-on work and close collaboration across functions. At Nanexa, you will not work in a silo. You will be involved across the organisation, working closely with colleagues in development, production and analytics, gaining a broad understanding of our technology, products and processes. As a company of approximately 15 employees, we offer an environment where each individual plays an important role, and where you will actively contribute to building something new. Responsibilities The QA Manager will have a central role in the oversight of manufacturing and analytical activities from a quality perspective, covering the entire chain from development to clinical supply. You will report directly to the Head of Quality Assurance and be an important contributor to the continued development of the QA function and the company as a whole. Your responsibilities will include: - Develop, implement and continuously improve the Quality Management System in line with company growth and regulatory requirements - Assess and approve batch-related documentation such as specifications, batch records, deviations and change requests - Ensure that production and testing of clinical trial materials are conducted in accordance with applicable GMP requirements - Review and approve SOPs, manage periodic reviews and support supplier qualification and re-evaluation - Lead and participate in internal audits and audits of external service providers - Represent QA in cross-functional project teams and contribute to project execution - Provide guidance and support to the organisation in quality-related matters - Perform internal training within GMP and quality systems - Contribute to the strategic development of the QA function and quality processes Your Profile We are looking for a driven and quality-minded professional who enjoys working in a dynamic and developing environment. Key qualifications include: - MSc in Pharmacy, Biology, Chemistry, Engineering, or a related field - Several years of experience within QA in a GMP-regulated pharmaceutical or biotech environment - Experience in development and/or validation of manufacturing or analytical processes - Experience in authoring and reviewing GxP-critical documentation, including SOPs, deviations, CAPAs and change controls - Strong knowledge of Quality Systems and applicable GMP regulations - Fluency in Swedish and English As a person, you are proactive, structured and solution-oriented, with a strong sense of ownership and accountability. You thrive in a dynamic organisation where processes are still being developed, and where you have the opportunity to make a real impact. You are comfortable taking on multiple responsibilities and enjoy working both independently and in close collaboration with others. At Nanexa, each employee contributes to the overall success of the company and you will have the opportunity to influence not only your own area of responsibility, but also the development of the company as a whole. About Nanexa AB Nanexa is a Swedish pharmaceutical company developing long-acting injectable drugs based on our proprietary PharmaShell® technology. We operate at the intersection of material science and drug development, taking projects from early idea through development to proof-of-concept in clinical trials. In addition to our own pipeline, we collaborate with leading pharmaceutical companies to develop new products based on our technology. To learn more about Nanexa, please visit www.nanexa.com For more information about the position, please contact: Krishan Johansson Haque, PhD Sr Recruitment Consultant, QRIOS Life Science & Engineering T: +46 (0)72-070 16 53 E: krishan.johansson-haque@qrios.se

The Quality Fabrication Manager will oversee quality assurance and control of all materials and equipment manufactured for the project, ensuring fabrication complies with contractual and CE marking requirements, technical specifications, inspection plans, and industry standards. A key part of the role is coordinating with suppliers, inspectors, logistics, and procurement to ensure all items are inspected, documented, and released before shipment. You will support the Project QA/QC Manager in implementing the quality management system for the fabrication phase, resolving quality issues, and ensuring timely delivery of compliant materials. Responsibilities Implement and maintain quality procedures for fabrication activities Review and approve suppliers' ITPs, welding/NDT procedures, coating plans, and fabrication documentation Coordinate inspections, FATs, dimensional checks, and material certificate traceability Manage NCRs, corrective actions, and QMS updates Work with procurement, logistics, and planning to ensure timely material release Lead the fabrication quality team and third-party inspectors Conduct supplier audits and monitor performance Prepare quality reports and attend project meetings Requirements 8+ years in fabrication quality management or similar roles Background in structural steel, piping, mechanical packages, pressure or electrical equipment fabrication Solid knowledge of QMS, inspection/testing methods, welding/NDT, coatings, and traceability Leadership and team management skills Ability to interpret technical documentation and inspection plans Experience in EPCM / PMC projects Degree in Mechanical, Industrial, or Materials Engineering (or similar) Quality certifications (ISO 9001, CSWIP, NACE, IWE/IWT) are a plus Fluent in English

Professional Galaxy is an IT and technology consulting company that provides highly specialized expertise within IT, software development, SAP, purchasing, electronics and mechanical design. We collaborate with experienced senior experts and deliver strategic value-creating expertise to some of Sweden's most complex and analytically demanding projects. Our focus is always on high quality, professionalism and clear, measurable results. We are now seeking a Supply Chain Manager for Clinical Trial medications for one of our clients. About the assignment: Would you like to utilize your planning and supply chain knowledge to lead clinical supplies for your portfolio of global clinical studies? With constant new products and launches, there has never been a better time to join Global Clinical Supply Chain and shape our future with a significant contribution to life-changing medicines. We have an exciting opportunity for talented Supply Chain Managers to join our Clinical Study Supply Chain team in Gothenburg, Sweden. This is a key role within our Clinical Manufacturing and Supply teams, and we make sure clinical trial medications are available at the right quality, in the right quantity at the right time for every patient taking part in xx trials all over the world. Our goal is to never miss a patient. In Pharmaceutical Technology and Development (PT&D) we are the bridge which turns forward-thinking science into actual medicines that help millions of people around the world. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Tasks and responsibilities/The role: In this role you will project manage the design, plan, and set-up of the study supply chain to ensure on time delivery of clinical supplies. You will also lead a cross-functional team enabling continuous dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study. To be successful in this role you need to be a fast learner, self-driven and comfortable working in a high pace R&D environment. You need to be a collaborative team player, flexible and have strong communication, planning and problem-solving skills. Your main responsibilities will include: • Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply. • Ensure effective communication with project teams and key partners across a global network. • Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies. • Take ownership for Inventory management including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction. • Manage the Interactive Response Technology (IRT) system to execute demand and supply planning. • Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls. Soft skills: • Strong influencing, negotiating and problem-solving skills, across geographical and cultural boundaries • Ability to adapt and operate in bespoke multiple systems. Desirable for the role: • Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice) • Knowledge of clinical development processes relevant to the supply of clinical materials • Lean knowledge and understanding • Experienced in handling Quality Events (Deviations, Change Controls, Complaints Location: Göteborg Start date: 2026-06-01 End date: 2027-05-31 Application Deadline: 2026-04-19 Are you the right person for the assignment, or do you want to recommend a strong candidate? Do not hesitate to contact us. Please apply directly through our system with: - Your updated CV in english - Availability to start the assignment In the motivation, describe why you are suitable for this assignment - refer to previous consulting assignments, employmxent, education and personal qualities. Please note: We do not accept any applications through mail. All applications have to be sent through the portal to be valid. Offer continuously: Please note that for this role we offer continuously. That means that we sometimes remove the assignments before the deadline. If you are interested, we recommend that you apply immediately.

Job Scope High level purpose of function.  Responsible for the development, validation, and execution of the methods used for material analysis, including incoming material, intermediate, and finalized products for Research & Development and Production on a wide range of instruments. Strict adherence to the principles of Quality Assurance in Quality Control (QA/QC). Proven track record in statistical analysis and measurement system analysis (MSA).  Key Responsibilities Overall areas of responsibilities and activities. Key responsibilities include (but are not limited to)  Responsible for a set of instrumentation or measurement systems. This involves, but not limited to, coordinating maintenance and troubleshooting, writing support documentation, training and qualifying personnel, performing method development and validation.   Understand and internalize QA/QC principles in everyday functions.   Conduct analysis on a wide range of instruments and report data/results for a diverse set of samples.   Execute the Quality Control and testing plan of material and components.  Maintaining instruments and measurement areas to a high standard, involving ownership of room(s)/area(s) to drive safety related topics, ensure 5S, maintain consumable inventory and standards/reference samples. Work across many parts of the organization, collaborating with R&D technical team, Process Quality Engineering, Process Engineering, Supply Chain, IT & automation.   Drive operational excellence and investigations by being a key player in problem solving and process improvement exercises.   Accountability/Authorization Budget responsibility: No  Direct reports: No  Work Environment responsibility: No All employees are accountable for complying with safety regulations and actively supporting a safe workplace. Requirements Educational background and previous experience required for the role. Qualifications and experience  Minimum MSc degree or Bachelor’s degree with 5+ years of work experience in a laboratory, in Chemistry, Material or Mechanical Engineering. 3+ years of relevant work experience in relevant laboratory environment.   Experience of laboratory work in relevant industries such as, e.g. Li-ion materials, Pharmaceutical, Food and Paper industries or automotive industries.   Experience in developing methods, standards, procedures, and documentation in an efficient way.   Familiarity with Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), Control Plan (CP), Lean, Six Sigma , Quality troubleshooting tools and problem-solving methodology.     Specific skills & Knowledge Specific knowledge in any relevant instrumentation, measurement system, or scientific field used by the company. Knowledgeable in Laboratory Information Management System (LIMS), quality management systems, e.g. ISO 9001, IATF16949, Total Quality Management (TQM).   Project management skills and a successful track record of leading quality projects in a laboratory environment.   Excellent English skills, both written and oral, are essential. Basic Swedish and other language skills are a plus. You should have good communication skills and be able to work in close collaboration with colleagues from many different teams.

Vill du ha en nyckelroll i att vidareutveckla, leda och förbättra kvalitetsledningssystem i en välmående och växande verksamhet där kvalitet, säkerhet och ständiga förbättringar står i fokus? Vi söker nu en engagerad och erfaren QMS Specialist som vill vara med och säkerställa att Skruf Snus produkter håller högsta kvalitet. Ditt uppdrag Som Quality Management System Specialist har du en central roll i att säkerställa och vidareutveckla Skruf Snus kvalitetsledningssystem. Du arbetar nära produktion, stödfunktioner och ledning med målet att driva förbättringsinitiativ kopplade till kvalitet, regelefterlevnad och säkerhet. Rollen kombinerar strategiskt arbete med operativa insatser och innebär mycket frihet under ansvar. Exempel på arbetsuppgifter: Etablera, förvalta och vidareutveckla kvalitetsledningssystem (QMS) enligt ISO 9001, ISO 14001 och ISO 45001 Planera, genomföra och följa upp interna revisioner samt stödja vid externa och regulatoriska revisioner Säkerställa efterlevnad av interna krav och externa regelverk genom riskbedömningar och trendanalyser (t.ex. FDA, EMA, ISO) Säkerställa korrekt livscykelhantering och utveckling av kvalitetsdokument (t.ex. Quality Manual, SOP:er och arbetsinstruktioner) Administrera och vidareutveckla eQMS samt stödja organisationen i dess användning Arbeta med avvikelser, CAPA och rotorsaksanalyser Följa upp kvalitets-KPI:er, bidra till utbildningsinsatser och till hög nivå av säkerhet och kvalitet i verksamheten Din profil Vi söker dig som har erfarenhet av att arbeta med kvalitetsledningssystem och som trivs i en roll där struktur, analys och förbättringsarbete står i fokus. Du har lätt för att samarbeta med olika funktioner, är kommunikativ och trygg i att driva frågor självständigt. Krav: Erfarenhet av arbete med kvalitetsledningssystem Förståelse för internationella standarder såsom ISO 9001, ISO 14001 God erfarenhet av eQMS-verktyg och dokumentstyrning Stark analytisk förmåga och erfarenhet av rotorsaksanalyser (ex. 5-why, Fishbone, DMAIC) Talar och skriver obehindrat på svenska samt har goda kunskaper i engelska Meriterande: Relevant högskole- eller universitetsutbildning Utbildning inom Lean, Six Sigma eller förbättringsarbete Erfarenhet av revisioner, CAPA-hantering och regulatoriska miljöer Tidigare erfarenhet från industri- eller tillverkningsmiljö ISO 45001 Vad vi erbjuder Hos Skruf Snus får du en varierad roll där du gör skillnad, både i fabriken och för våra kunder. Du blir en del av ett engagerat team med starkt fokus på kvalitet, samarbete och ständig förbättring. Du erbjuds även konkurrenskraftiga villkor och goda utvecklingsmöjligheter. Skruf Snus är Nordens näst största snustillverkare med över 300 medarbetare, och vi fortsätter att växa. Inte bara med en stark position på den svenska marknaden, men också på den europeiska. Läs mer på www.skruf.se. Skruf Snus ingår i den globala koncernen Imperial Brands med verksamhet i över 120 marknader. Vi är ett inkluderande och innovativt globalt FMCG-företag med 25 000 medarbetare världen över. Ansökan I den här rekryteringen samarbetar Skruf Snus med Jefferson Wells och du blir anställd direkt hos Skruf Snus. Vid frågor är du välkommen att kontakta ansvarig rekryteringskonsult Eva Ekdahl på Eva.Ekdahl@jeffersonwells.se. Urval sker löpande, så skicka in din ansökan så snart som möjligt. Tjänsten är 100% på plats i fabriken i Sävsjö. Vi ser fram emot att höra från dig, välkommen med din ansökan!

51263 Vill du ha en nyckelroll i att vidareutveckla, leda och förbättra kvalitetsledningssystem i en välmående och växande verksamhet där kvalitet, säkerhet och ständiga förbättringar står i fokus? Vi söker nu en engagerad och erfaren QMS Specialist som vill vara med och säkerställa att Skruf Snus produkter håller högsta kvalitet. Ditt uppdrag Som Quality Management System Specialist har du en central roll i att säkerställa och vidareutveckla Skruf Snus kvalitetsledningssystem. Du arbetar nära produktion, stödfunktioner och ledning med målet att driva förbättringsinitiativ kopplade till kvalitet, regelefterlevnad och säkerhet. Rollen kombinerar strategiskt arbete med operativa insatser och innebär mycket frihet under ansvar. Exempel på arbetsuppgifter: Etablera, förvalta och vidareutveckla kvalitetsledningssystem (QMS) enligt ISO 9001, ISO 14001 och ISO 45001 Planera, genomföra och följa upp interna revisioner samt stödja vid externa och regulatoriska revisioner Säkerställa efterlevnad av interna krav och externa regelverk genom riskbedömningar och trendanalyser (t.ex. FDA, EMA, ISO) Säkerställa korrekt livscykelhantering och utveckling av kvalitetsdokument (t.ex. Quality Manual, SOP:er och arbetsinstruktioner) Administrera och vidareutveckla eQMS samt stödja organisationen i dess användning Arbeta med avvikelser, CAPA och rotorsaksanalyser Följa upp kvalitets-KPI:er, bidra till utbildningsinsatser och till hög nivå av säkerhet och kvalitet i verksamheten Din profil Vi söker dig som har erfarenhet av att arbeta med kvalitetsledningssystem och som trivs i en roll där struktur, analys och förbättringsarbete står i fokus. Du har lätt för att samarbeta med olika funktioner, är kommunikativ och trygg i att driva frågor självständigt. Krav: Erfarenhet av arbete med kvalitetsledningssystem Förståelse för internationella standarder såsom ISO 9001, ISO 14001 God erfarenhet av eQMS-verktyg och dokumentstyrning Stark analytisk förmåga och erfarenhet av rotorsaksanalyser (ex. 5-why, Fishbone, DMAIC) Talar och skriver obehindrat på svenska samt har goda kunskaper i engelska Meriterande: Relevant högskole- eller universitetsutbildning Utbildning inom Lean, Six Sigma eller förbättringsarbete Erfarenhet av revisioner, CAPA-hantering och regulatoriska miljöer Tidigare erfarenhet från industri- eller tillverkningsmiljö ISO 45001 Vad vi erbjuder Hos Skruf Snus får du en varierad roll där du gör skillnad, både i fabriken och för våra kunder. Du blir en del av ett engagerat team med starkt fokus på kvalitet, samarbete och ständig förbättring. Du erbjuds även konkurrenskraftiga villkor och goda utvecklingsmöjligheter. Skruf Snus är Nordens näst största snustillverkare med över 300 medarbetare, och vi fortsätter att växa. Inte bara med en stark position på den svenska marknaden, men också på den europeiska. Läs mer på www.skruf.se. Skruf Snus ingår i den globala koncernen Imperial Brands med verksamhet i över 120 marknader. Vi är ett inkluderande och innovativt globalt FMCG-företag med 25 000 medarbetare världen över. Ansökan I den här rekryteringen samarbetar Skruf Snus med Jefferson Wells och du blir anställd direkt hos Skruf Snus. Vid frågor är du välkommen att kontakta ansvarig rekryteringskonsult Eva Ekdahl på Eva.Ekdahl@jeffersonwells.se. Urval sker löpande, så skicka in din ansökan så snart som möjligt. Tjänsten är 100% på plats i fabriken i Sävsjö. Vi ser fram emot att höra från dig, välkommen med din ansökan!

51263 Vill du ha en nyckelroll i att vidareutveckla, leda och förbättra kvalitetsledningssystem i en välmående och växande verksamhet där kvalitet, säkerhet och ständiga förbättringar står i fokus? Vi söker nu en engagerad och erfaren QMS Specialist som vill vara med och säkerställa att Skruf Snus produkter håller högsta kvalitet. Ditt uppdrag Som Quality Management System Specialist har du en central roll i att säkerställa och vidareutveckla Skruf Snus kvalitetsledningssystem. Du arbetar nära produktion, stödfunktioner och ledning med målet att driva förbättringsinitiativ kopplade till kvalitet, regelefterlevnad och säkerhet. Rollen kombinerar strategiskt arbete med operativa insatser och innebär mycket frihet under ansvar. Exempel på arbetsuppgifter: Etablera, förvalta och vidareutveckla kvalitetsledningssystem (QMS) enligt ISO 9001, ISO 14001 och ISO 45001 Planera, genomföra och följa upp interna revisioner samt stödja vid externa och regulatoriska revisioner Säkerställa efterlevnad av interna krav och externa regelverk genom riskbedömningar och trendanalyser (t.ex. FDA, EMA, ISO) Säkerställa korrekt livscykelhantering och utveckling av kvalitetsdokument (t.ex. Quality Manual, SOP:er och arbetsinstruktioner) Administrera och vidareutveckla eQMS samt stödja organisationen i dess användning Arbeta med avvikelser, CAPA och rotorsaksanalyser Följa upp kvalitets-KPI:er, bidra till utbildningsinsatser och till hög nivå av säkerhet och kvalitet i verksamheten Din profil Vi söker dig som har erfarenhet av att arbeta med kvalitetsledningssystem och som trivs i en roll där struktur, analys och förbättringsarbete står i fokus. Du har lätt för att samarbeta med olika funktioner, är kommunikativ och trygg i att driva frågor självständigt. Krav: Erfarenhet av arbete med kvalitetsledningssystem Förståelse för internationella standarder såsom ISO 9001, ISO 14001 God erfarenhet av eQMS-verktyg och dokumentstyrning Stark analytisk förmåga och erfarenhet av rotorsaksanalyser (ex. 5-why, Fishbone, DMAIC) Talar och skriver obehindrat på svenska samt har goda kunskaper i engelska Meriterande: Relevant högskole- eller universitetsutbildning Utbildning inom Lean, Six Sigma eller förbättringsarbete Erfarenhet av revisioner, CAPA-hantering och regulatoriska miljöer Tidigare erfarenhet från industri- eller tillverkningsmiljö ISO 45001 Vad vi erbjuder Hos Skruf Snus får du en varierad roll där du gör skillnad, både i fabriken och för våra kunder. Du blir en del av ett engagerat team med starkt fokus på kvalitet, samarbete och ständig förbättring. Du erbjuds även konkurrenskraftiga villkor och goda utvecklingsmöjligheter. Skruf Snus är Nordens näst största snustillverkare med över 300 medarbetare, och vi fortsätter att växa. Inte bara med en stark position på den svenska marknaden, men också på den europeiska. Läs mer på www.skruf.se. Skruf Snus ingår i den globala koncernen Imperial Brands med verksamhet i över 120 marknader. Vi är ett inkluderande och innovativt globalt FMCG-företag med 25 000 medarbetare världen över. Ansökan I den här rekryteringen samarbetar Skruf Snus med Jefferson Wells och du blir anställd direkt hos Skruf Snus. Vid frågor är du välkommen att kontakta ansvarig rekryteringskonsult Eva Ekdahl på Eva.Ekdahl@jeffersonwells.se. Urval sker löpande, så skicka in din ansökan så snart som möjligt. Tjänsten är 100% på plats i fabriken i Sävsjö. Vi ser fram emot att höra från dig, välkommen med din ansökan!

51263 Vill du ha en nyckelroll i att vidareutveckla, leda och förbättra kvalitetsledningssystem i en välmående och växande verksamhet där kvalitet, säkerhet och ständiga förbättringar står i fokus? Vi söker nu en engagerad och erfaren QMS Specialist som vill vara med och säkerställa att Skruf Snus produkter håller högsta kvalitet. Ditt uppdrag Som Quality Management System Specialist har du en central roll i att säkerställa och vidareutveckla Skruf Snus kvalitetsledningssystem. Du arbetar nära produktion, stödfunktioner och ledning med målet att driva förbättringsinitiativ kopplade till kvalitet, regelefterlevnad och säkerhet. Rollen kombinerar strategiskt arbete med operativa insatser och innebär mycket frihet under ansvar. Exempel på arbetsuppgifter: Etablera, förvalta och vidareutveckla kvalitetsledningssystem (QMS) enligt ISO 9001, ISO 14001 och ISO 45001 Planera, genomföra och följa upp interna revisioner samt stödja vid externa och regulatoriska revisioner Säkerställa efterlevnad av interna krav och externa regelverk genom riskbedömningar och trendanalyser (t.ex. FDA, EMA, ISO) Säkerställa korrekt livscykelhantering och utveckling av kvalitetsdokument (t.ex. Quality Manual, SOP:er och arbetsinstruktioner) Administrera och vidareutveckla eQMS samt stödja organisationen i dess användning Arbeta med avvikelser, CAPA och rotorsaksanalyser Följa upp kvalitets-KPI:er, bidra till utbildningsinsatser och till hög nivå av säkerhet och kvalitet i verksamheten Din profil Vi söker dig som har erfarenhet av att arbeta med kvalitetsledningssystem och som trivs i en roll där struktur, analys och förbättringsarbete står i fokus. Du har lätt för att samarbeta med olika funktioner, är kommunikativ och trygg i att driva frågor självständigt. Krav: Erfarenhet av arbete med kvalitetsledningssystem Djup förståelse för internationella standarder såsom ISO 9001, ISO 14001 och ISO 45001 God erfarenhet av eQMS-verktyg och dokumentstyrning Stark analytisk förmåga och erfarenhet av rotorsaksanalyser (ex. 5-why, Fishbone, DMAIC) Talar och skriver obehindrat på svenska samt har goda kunskaper i engelska Meriterande: Relevant högskole- eller universitetsutbildning Utbildning inom Lean, Six Sigma eller förbättringsarbete Erfarenhet av revisioner, CAPA-hantering och regulatoriska miljöer Tidigare erfarenhet från industri- eller tillverkningsmiljö Vad vi erbjuder Hos Skruf Snus får du en varierad roll där du gör skillnad, både i fabriken och för våra kunder. Du blir en del av ett engagerat team med starkt fokus på kvalitet, samarbete och ständig förbättring. Du erbjuds även konkurrenskraftiga villkor och goda utvecklingsmöjligheter. Skruf Snus är Nordens näst största snustillverkare med över 300 medarbetare, och vi fortsätter att växa. Inte bara med en stark position på den svenska marknaden, men också på den europeiska. Läs mer på www.skruf.se. Skruf Snus ingår i den globala koncernen Imperial Brands med verksamhet i över 120 marknader. Vi är ett inkluderande och innovativt globalt FMCG-företag med 25 000 medarbetare världen över. Ansökan I den här rekryteringen samarbetar Skruf Snus med Jefferson Wells och du blir anställd direkt hos Skruf Snus. Vid frågor är du välkommen att kontakta ansvarig rekryteringskonsult Eva Ekdahl på Eva.Ekdahl@jeffersonwells.se. Urval sker löpande, så skicka in din ansökan så snart som möjligt, dock senast 31 maj. Tjänsten är 100% på plats i fabriken i Sävsjö. Vi ser fram emot att höra från dig, välkommen med din ansökan!

Hansa Biopharma develops innovative treatments that give patients with rare and serious immune-mediated conditions a chance to a better life. We are now looking for an experienced Senior QA Manager Validation and Quality, to help shape our quality work at one of the most exciting biotech companies in the Nordics. About the role You will be a key player in a QA team of six dedicated colleagues, all based at our office in Lund. As Senior QA Manager, you will drive and approve validation activities - spanning process, cleaning and analytical method validation - with a clear quality perspective. You will act as subject matter expert supporting cross-functional teams, external partner management and regulatory authority inspections. This is the right role for you if you thrive with both strategic ownership and operational presence - where one day you are reviewing validation documentation and the next you are in dialogue with a CDMO or preparing a team for an authority inspection. Your responsibilities: Provide strategic and operational direction for quality management and validation across development, clinical and commercial manufacturing QA review and approval of validation documentation Supplier quality management: guide and qualify external manufacturing partners (CDMOs/CMOs) throughout the product lifecycle Support authority inspections and internal/external audits of suppliers and vendors Cross-functional collaboration with CMC, Regulatory, Clinical and Supply Chain Drive continuous improvement of the Quality Management System (QMS) and proactively identify areas for development Who are you? We believe you are a seasoned QA professional with broad experience across both drug substance (DS) and drug product (DP) manufacturing. You are thorough and results-oriented, but also a natural collaborator who knows when to take the lead and when to seek input from others. We are looking for someone with: Advanced degree (Ph.D. or M.Sc.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related discipline 10+ years of biopharmaceutical industry experience with a focus on QA, process development and validation Proven track record of leading validation activities for DS and DP through clinical and commercial stages Strong knowledge of aseptic manufacturing and biotechnology processes Deep understanding of regulatory requirements (FDA, EMA, ICH) related to manufacturing and validation Experience managing external partners and CDMOs/CMOs Experience of authority inspections (FDA, EMA) as presenter and/or coordinator Strong communication skills and the ability to influence across functions and organisational levels What we offer At Hansa, you will not just have a job - you will have a role where your work directly contributes to changing lives for patients with acute and complex immune disorders. A close-knit, welcoming culture in a mid-sized company where you can see how your contribution makes a difference The opportunity to help build a fully integrated biopharmaceutical company with global reach Talented, driven colleagues with an open and entrepreneurial mindset A strong pipeline built on Hansa’s proprietary IgG-cleaving enzyme technology platform Office in Lund, at the heart of a vibrant Life Science ecosystem Our values At Hansa, we are guided by our core values: Accountability, Courage, Integrity and Pioneering. We believe in the power of diversity and are committed to building an inclusive workplace where every perspective is valued. Appealing? Send in an application as soon as possible. In this recruitment, Hansa Biopharma is collaborating with SallyQ. For questions, please contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se.

Job Scope High level purpose of function.  The Production Quality Engineer is responsible for one or more production areas to ensure across the organization that Quality Assurance principles are strictly adhered to. This involves working closely with manufacturing and engineering to support improvement processes to ensure a flawless transition into manufacturing. Specifically, to take part in the specific processes, support in their performance and results, providing technical expertise and guidance to the team to reach targets assigned. Key Responsibilities Overall areas of responsibilities and activities. Key responsibilities include (but are not limited to)  Lead quality assurance activities in production ensure that production/product quality specifications are met. Lead and train quality team members and operations on quality standards and procedures. Perform onboarding and attendance timesheets validation related to led team members. Lead problem solving and root cause analysis activities in relation to deviations and quality issues, e.g., 8D and non-conformity investigations. Contribute to FMEA reviews. Lead launch activities to ensure the deliverables of different projects. Collaborate cross-functionally on shopfloor to improve manufacturing processes and implements solutions. Monitor NCM processes and ensure closing of actions in defined time. Update and monitor the Quality Control plans for each process operation. Define and improve Work instructions and procedures for Quality related activities. Monitor quality procedures, quality KPI's, evaluate performance and make improvement proposals, i.e., Process capability: SPC and Cpk. Define and monitor MSA activities. Develop, implement, and audit standard instructions. Implement and audit standard procedures. Plan and perform product / process audits and lead action plan to comply with customer's requirements and IATF 16949 and VDA. Contribute/lead scrap reduction action plan and improvements implementation.  Accountability/Authorization ​​Budget responsibility:​ ​No​ ​​Direct reports:​ ​No​ Work Environment Responsibility: No All employees are accountable for complying with safety regulations and actively supporting a safe workplace. Requirements Educational background and previous experience required for the role. Qualifications and experience  Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience Experience of quality work in relevant industries such as, e.g. Li-ion materials, Pharmaceutical, Food and Paper industries, or automotive industries. Experience with Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), Control Plan (CP), Lean, Six Sigma, Quality troubleshooting tools and problem-solving methodology. Specific skills & Knowledge Excellent English skills, both written and oral, are essential. Basic Swedish and other language skills are a plus. You should have good communication skills and be able to work in close collaboration with colleagues from many different teams.   Knowledge in Quality Management Systems (QMS), such as, ISO 9001, IATF16949, and Total Quality Management (TQM) principles. Project management skills and a successful track record of leading quality projects in a manufacturing or similar environment.