Quality engineer

Your Role

In 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 Responsibilities

• Maintain and develop the Quality Management System (QMS) in accordance with regulatory requirements and industry standards

• Maintain Device Master Records (DMR) and ensure documentation accuracy and completeness

• Support QA release activities, including reviewing and organizing release documentation

• Manage document control, ensuring accurate versioning and timely routing of procedures, forms, and records

• Coordinate internal audit programs and follow up on audit findings and corrective actions.

• Support deviation management and CAPA processes

• Compile and monitor quality metrics, dashboards, and management reports

• Contribute to process improvement initiatives and quality-related projects

• Contribute to external audits and regulatory inspections

What We Expect From You

• Bachelors or Masters degree in Engineering or another relevant field

• Experience in quality assurance within the medical device industry or another regulated environment

• Experience working in a manufacturing environment and with production quality activities, product release processes, and manufacturing documentation

• Good understanding of ISO 13485, FDA 21 CFR Part 820, and related regulatory requirements

• Experience with Quality Management Systems and document control processes

• Experience working with ERP and/or eQMS systems is considered an advantage

• Strong analytical thinking and problem-solving skills

• Good communication and collaboration skills in both Finnish and English

• Good documentation and technical writing skills in Finnish and English

• Ability to work independently and manage multiple priorities

• Experience with supplier quality management and product release activities is considered an advantage

What We Offer

• A meaningful role in a growing international medical device company

• The opportunity to contribute to the development and improvement of quality processes

• Collaboration with skilled and supportive cross-functional teams

• Meaningful work that contributes to patient safety and well-being

• Competitive compensation and benefits

• A position located in Tampere with the possibility for occasional remote work

Bioretec Oy

Bioretec Oy on suomalainen, globaalisti toimiva lääkinnällisiä laitteita valmistava yhtiö ja biohajoavien ortopedisten implanttien edelläkävijä. Yhtiöllä on ainutlaatuista materiaalitekniikan ja biokemian yhdistävää osaamistaaktiivisista implanteista, jotka edistävät luun kasvua ja nopeuttavat murtumien paranemista ortopedisten leikkausten jälkeen. Bioretecin kehittämiä ja valmistamia tuotteita käytetään noin 40 maassa ympäri maailmaa. Yhtiön RemeOs-tuoteperheen ensimmäiselle tuotteelle saatiin myyntilupa Yhdysvalloissamaaliskuussa 2023 ja Euroopassa tammikuussa 2025. Bioretec on listattu Nasdaq First North Growth Market -markkinapaikalla kaupankäyntitunnuksella BRETEC. Yhtiön tuotantolaitos sijaitsee Tampereen Hankkiossa ja tytäryritykset Itävallassa ja Yhdysvalloissa.