Kvalitetsingenjör - Bioretec Oy - Tammerfors, Finland

Your RoleIn this role, you will be responsible for maintaining and developing our Quality Management System (QMS) and supporting product release activities. You will ensure that quality documentation and records management processes comply with applicable regulatory requirements and industry standards. In addition, you will support internal and external audits and contribute to the continuous improvement of quality processes. Key ResponsibilitiesMaintain and develop the Quality Management System (QMS) in accordance with regulatory requirements and industry standardsMaintain Device Master Records (DMR) and ensure documentation accuracy and completenessSupport QA release activities, including reviewing and organizing release documentationManage document control, ensuring accurate versioning and timely routing of procedures, forms, and recordsCoordinate internal audit programs and follow up on audit findings and corrective actions.Support deviation management and CAPA processesCompile and monitor quality metrics, dashboards, and management reportsContribute to process improvement initiatives and quality-related projectsContribute to external audits and regulatory inspections What We Expect From YouBachelor’s or Master’s degree in Engineering or another relevant fieldExperience in quality assurance within the medical device industry or another regulated environmentExperience working in a manufacturing environment and with production quality activities, product release processes, and manufacturing documentationGood understanding of ISO 13485, FDA 21 CFR Part 820, and related regulatory requirementsExperience with Quality Management Systems and document control processesExperience working with ERP and/or eQMS systems is considered an advantageStrong analytical thinking and problem-solving skillsGood communication and collaboration skills in both Finnish and EnglishGood documentation and technical writing skills in Finnish and EnglishAbility to work independently and manage multiple prioritiesExperience with supplier quality management and product release activities is considered an advantageWhat We OfferA meaningful role in a growing international medical device companyThe opportunity to contribute to the development and improvement of quality processesCollaboration with skilled and supportive cross-functional teamsMeaningful work that contributes to patient safety and well-beingCompetitive compensation and benefitsA position located in Tampere with the possibility for occasional remote workHow to ApplyIf you are interested in applying, please submit your application together with your CV by May 31, 2026. Applications will be reviewed on an ongoing basis. For further information about the role, please contact Mirva Ekman, mirva.ekman@bioretec.com.Equal OpportunityBioretec is an equal opportunity employer committed to creating an inclusive and diverse workplace. We welcome applications from all qualified candidates regardless of gender, age, ethnicity, religion, disability, sexual orientation, or background.