Sterility Assurance Lead, Galderma (Uppsala)

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.

ABOUT US Our mission at Avelios is to unlock clinical data to power seamless healthcare operations for better patient care. To do so, we have built a modular software platform that digitizes and optimizes workflows in hospitals with cutting-edge technology in a user-friendly way. With our software, we enable hospitals, doctors & nurses to provide their patients with the best possible care. We are growing fast and want to keep expanding our team and business to fundamentally digitize healthcare for the better. We appreciate different backgrounds and see diversity as one of our strengths. THE TEAM AND ROLE Avelios Medical is expanding its quality function and introducing a QA Lead to establish and own our end-to-end testing and quality processes. You will create the structure that ensures our product is reliable, safe, and release-ready at all times. You will lead and grow a team of Software Testers that perform manual tests, define the QA operating model and strategy, and coordinate closely with Engineering on test automation and CI/CD integration. YOUR RESPONSIBILITIES * Define a unified QA strategy as well as processes, standards and quality gates across manual and automated testing * Lead and grow the QA team for manual software testing and oversee test case and test evidence quality and act as the central contact for Product and Engineering to decide on testing depth and needs * Establish the strategy for test automation and coordinate execution with Engineering * Own planning and execution of regression cycles and release-readiness checks * Ensure all test protocols are complete, reproducible, and audit-ready * Evaluate and recommend tools for test management, automation, and reporting * Evaluate QA metrics and drive continuous improvements in coverage, stability, and cycle time * Collaborate closely with Product Management and Engineering Leadership YOUR QUALIFICATIONS * Deep experience in software QA, including designing and governing QA processes and standards, that are auditable * Track record leading manual and automated testing in complex products; experience in regulated or quality-critical domains is a plus * Experience in growing and leading a team of Software Testers * Strong understanding of software testing methodologies, modern test automation, CI/CD, and engineering workflows * Ability to coordinate across teams, create structure, and drive disciplined execution * Clear, structured communicator able to justify quality decisions and trade-offs * Able to interpret defect data and identify systemic root causes YOUR BENEFITS * Variety in your tasks and the opportunity to take ownership * An international, informal team structure in a motivating start-up atmosphere, allowing you to participate directly in our customer growth story and the overall success of Avelios * Ability to gain valuable hands-on experience in a startup backed by leading international VCs * Support for your personal development through continuous learning and feedback * Set your own rhythm with flexible working hours and trust-based time tracking * A virtual stock option package (VSOP) that lets you participate in Avelios’ long-term value creation * A monthly meal allowance up to 75 euros, full coverage of the Deutschlandticket, Urban Sports Club or a subsidized Wellpass membership, a bike leasing program and Corporate Benefits that give you access to discounts from a wide range of providers in various areas