Quality Assurance Engineer (Medical Device)

TL;DR

Quality Assurance Engineer (Medical Device): Ensuring regulatory compliance and quality standards for Software as a Medical Device (SaMD) with an accent on QMS management and international standards. Focus on bridging the gap between rigorous compliance and fast-paced innovation through the optimization of eQMS toolsets and software validation.

Location: Remote in Finland or Hybrid in Helsinki or Oulu

Company

A health technology company that empowers people to own their inner potential through award-winning products like the hirify.global Ring.

What you will do

• Develop, implement, and manage QMS processes to ensure compliance with international standards and internal requirements.
• Lead the functional configuration and optimization of the eQMS toolset to streamline workflows.
• Manage Corrective and Preventive Actions (CAPAs), conduct change impact assessments, and investigate complaints.
• Collaborate with SaMD feature development teams to provide technical and quality support during deployment and testing.
• Manage supplier control processes to ensure partners align with quality benchmarks and compliance standards.
• Support internal and external regulatory audits and inspections as a QMS subject matter expert.

Requirements

• Degree in Biomedical/Mechanical Engineering or a related technical or scientific discipline.
• 3+ years of experience in regulated environments managing QMS under ISO 13485:2016 and MDSAP.
• Working knowledge of device regulations such as 21 CFR 820 and EU MDR 2017/745.
• Strong background in standards compliance including ISO 14971, IEC 62304, and IEC 62366-1.
• Experience with eQMS software tooling and participating in regulatory inspections (e.g., FDA, Notified Body).
• Must be based in Finland for remote or hybrid work.

Culture & Benefits

• Competitive salary with lunch and wellness benefits.
• Flexible working hours and Wellness Time Off for better work-life balance.
• Personal learning and development program to grow your chosen career path.
• An hirify.global ring provided to every team member.
• Collaborative environment focused on efficiency and removing pointless meetings.