Quality lead

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA. In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide. Key Responsibilities As a Cleanliness & Sterility Assurance Engineer, you will: Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications. Lead and execute cleanliness process validations for new and updated manufacturing equipment. Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager. Maintain and update contact material mapping documentation. Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes. Support biological and microbiological safety strategies across the organization. Coordinate and manage external testing activities with approved laboratories and vendors when required. Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives. Qualifications and Experience To succeed in this role, you should have: A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline. At least 5 years of experience within the Medical Device industry or a comparable regulated environment. Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision. Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2. A solid understanding of manufacturing processes and process validation methodologies. Strong expertise in statistical analysis and interpretation of technical data. Excellent communication skills, both written and verbal. Fluency in English. Swedish language skills are considered an advantage. A structured, analytical, and problem-solving mindset.

Join our dynamic Manufacturing Production team and drive excellence in our state-of-the-art manufacturing facilities! We're seeking a Senior Professional to lead critical production processes and enhance our operational technology security landscape. What will you do: Lead specialized areas of manufacturing processes including process design, ergonomics, capacity planning, and performance optimization Spearhead OT Cybersecurity initiatives to protect manufacturing infrastructure and enhance plant cyber resilience Manage production activities to meet quality standards, schedules, and cost targets while minimizing waste Drive continuous improvement projects across production operations Collaborate with cross-functional teams to optimize production schedules and resource allocation   What will make you successful: Demonstrated expertise in manufacturing production processes and operations Strong background in OT Cybersecurity and infrastructure protection Track record of implementing process improvements and achieving operational excellence Ability to manage complex projects and lead cross-functional teams Excellence in stakeholder management and communication skills What's in it for you: Opportunity to shape the future of manufacturing excellence and cybersecurity Lead innovative projects that drive operational transformation Development of expertise across multiple manufacturing disciplines Collaborative environment fostering professional growth Impact on critical business operations and strategic initiatives   Let us learn about you! Apply today. Looking to make an IMPACT with your career? When you are thinking about joining a new team, culture matters. At Schneider Electric, our values and behaviors are the foundation for creating a great culture to support business success. We believe that our  IMPACT values – Inclusion, Mastery, Purpose, Action, Curiosity, Teamwork – starts with us. IMPACT is also your invitation to join Schneider Electric where you can contribute to turning sustainability ambition into actions, no matter what role you play. It is a call to connect your career with the ambition of achieving a more resilient, efficient, and sustainable world. We are looking for IMPACT Makers; exceptional people who turn sustainability ambitions into actions at the intersection of automation, electrification, and digitization. We celebrate IMPACT Makers and believe everyone has the potential to be one. Become an IMPACT Maker with Schneider Electric – apply today! €40 billion global revenue +9% organic growth 150 000+ employees in 100+ countries You must submit an online application to be considered for any position with us. This position will be posted until filled. Schneider Electric aspires to be the most inclusive and caring company in the world, by providing equitable opportunities to everyone, everywhere, and ensuring all employees feel uniquely valued and safe to contribute their best. We mirror the diversity of the communities in which we operate, and ‘inclusion’ is one of our core values. We believe our differences make us stronger as a company and as individuals and we are committed to championing inclusivity in everything we do. At Schneider Electric, we uphold the highest standards of ethics and compliance, and we believe that trust is a foundational value. Our Trust Charter is our Code of Conduct and demonstrates our commitment to ethics, safety, sustainability, quality and cybersecurity, underpinning every aspect of our business and our willingness to behave and respond respectfully and in good faith to all our stakeholders. You can find out more about our Trust Charter here   Schneider Electric is an Equal Opportunity Employer. It is our policy to provide equal employment and advancement opportunities in the areas of recruiting, hiring, training, transferring, and promoting all qualified individuals regardless of race, religion, color, gender, disability, national origin, ancestry, age, military status, sexual orientation, marital status, or any other legally protected characteristic or conduct.