Global QA Manager – ISO 15189 / CAP, Med Device & Lab

Blueprint Genetics Oy; Espoo; Hybrid; EUR 90,000 - 140,000; Full time

Benefits offered by this job

Performance-based bonus

Extensive occupational healthcare

Sports, culture & wellbeing benefits

On-site gym membership

Job summary

Blueprint Genetics Oy, a Quest Diagnostics company, is seeking an experienced Quality Assurance Manager to lead the QA team in Finland and continuously improve the QMS across laboratory and medical device operations.

The role ensures compliance with ISO 15189, CAP, NY CLEP, ISO 13485 and IVDR, while driving a culture of quality and continuous improvement globally. Hybrid work in Espoo with occasional travel may be required.

Qualifications

• Bachelor’s or master’s degree in life sciences, engineering or related field.
• Solid working experience with medical device and clinical lab quality assurance.
• Extensive understanding of ISO15189, ISO13485 and IVDR regulations.
• Previous people leader experience and ability to set goals and drive performance.
• Business acumen and international exposure.
• Ability to collaborate across functions and geographic boundaries.
• Ability to maintain compliance and drive process improvements.
• Ability to plan long-term projects and meet deadlines.
• Excellent verbal and written communication in English and Finnish.
• Occasional flexibility with working hours to meet different time zones.

Responsibilities

• Lead the Quality Assurance team and set performance and development goals.
• Develop and improve the QMS for Blueprint Genetics Finland in compliance with standards.
• Act as clinical lab quality manager per ISO 15189 and NY CLEP.
• Execute quality and regulatory strategy and monitor KPIs.
• Collaborate with Regulatory Affairs, Product Development and Operations.
• Coordinate QA activities with US counterparts to align processes.

Skills

Quality Assurance

Team Leadership

Regulatory Knowledge

Analytical Thinking

Cross-functional Collaboration

English & Finnish

Education

Bachelor’s or Master’s degree in life sciences/engineering

Tools

QMS systems

Job description

Blueprint Genetics Oy, a Quest Diagnostics company, is seeking an experienced Quality Assurance Manager to lead the QA team in Finland and continuously improve the QMS across laboratory and medical device operations.

The role ensures compliance with ISO 15189, CAP, NY CLEP, ISO 13485 and IVDR, while driving a culture of quality and continuous improvement globally. Hybrid work in Espoo with occasional travel may be required.