Quality Assurance Manager

About the role

We are seeking an experienced Quality Assurance Manager to lead our QA team in Finland and continuously improve our Quality Management System across both clinical laboratory and medical device operations. The role ensures compliance with ISO 15189, CAP, NY CLEP, ISO 13485, IVDR and other regulatory requirements while supporting our mission to bring genetic knowledge to mainstream healthcare.

Key responsibilities

• Lead a team of three quality assurance professionals, setting performance and development goals.
• Develop, maintain and improve Blueprint Genetics Finland’s Quality Management System in line with applicable standards and regulations.
• Ensure ongoing compliance with ISO 15189, CAP, NY CLEP, ISO 13485, IVDR and related regulatory requirements.
• Monitor key performance indicators, make fact‑based decisions and report results to senior leadership.
• Collaborate cross‑functionally with laboratory leadership, Regulatory Affairs, Product Development, Operations and US counterparts to embed quality across processes.
• Execute the quality and regulatory strategy and drive annual targets.

Required profile

• Professional experience in medical device or clinical laboratory quality assurance.
• Strong knowledge of ISO 15189, CAP, ISO 13485, IVDR and related regulatory frameworks.
• Proven ability to lead and develop a QA team.
• Experience working in a global, cross‑functional environment.

Required skills

• ISO 15189
• CAP accreditation standards
• ISO 13485
• IVDR compliance
• Regulatory affairs knowledge