Quality Assurance Manager
HybridEspoo, Uusimaa, Finland
Job Summary
Lead the Quality Assurance team in Finland by maintaining and improving the Quality Management System across laboratory and medical device operations. Ensure compliance with ISO 15189, CAP, NY CLEP, ISO 13485, and IVDR while executing the quality and regulatory strategy. Monitor key performance indicators, analyze data, and report results to drive fact-based decisions. Set annual targets, provide QA training, and represent the site in audits and vigilance processes. Work cross-functionally with leadership, Regulatory Affairs, and Product Development to embed quality into all business processes and align local activities with global corporate policies.
Required Qualifications
- Bachelor's or master's degree in life sciences, engineering or other relevant education
- Solid working experience with medical device and clinical lab quality assurance
- Extensive understanding of applicable regulations and industry standards, inclusive of ISO15189, ISO13485 and IVDR
- Previous people leader experience and ability to set goals, motivate and drive performance
- Good business acumen and international exposure
- Ability to build partnerships and work with people at all levels of the organization and across geographic boundaries to achieve common goals
- Ability to maintain compliance and improve processes through facilitation, teamwork, effective communication and influencing skills
- Ability to organize long-term project plans and meet assigned targets and deadlines
- Excellent verbal and written communication skills in English and Finnish
- Occasional flexibility with working hours to meet different time zone requirement
- Must be able to work in a rapidly changing, global matrix environment
- Must be able to fit the inclusive and international culture of Blueprint Genetics and Quest Diagnostics
- Must be able to work partly remotely
- Must be able to work in Keilaniemi, Espoo
Desired Qualifications
- Enthusiasm about being a people lead
- Self-driven, proactive, and analytical way of working
- Quick decision-making ability
- Ability to find insightful and practical solutions to daily challenges
- Ability to analyze existing processes and data and identify opportunities for process and workflow improvements
- Ability to maintain compliance and improve processes through facilitation, teamwork, effective communication and influencing skills
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