About this role
Job title: Quality Assurance Manager
About the Role Join Our Team as a Quality Assurance Manager – Drive Excellence in Medical Device Quality! We are seeking an innovative and detail-oriented leader to oversee quality initiatives from Maastricht and harmonise our Quality Management System across Canada, South Africa, and EMEA. Reporting to the Senior Director of Quality, you will manage a team and ensure our manufacturing processes meet the highest standards.
What You'll Do
- Lead the quality team in Maastricht (seven staff, including two direct reports) and drive product quality and QMS harmonisation across sites and regions.
- Develop, implement, and monitor quality systems across multiple sites; ensure manufacturing processes comply with ISO 13485 and 21 CFR Part 820.
- Collaborate with global teams and report to the Senior Director of Quality to maintain our reputation for quality and compliance.
- Identify and drive continuous improvement opportunities; analyse issues and implement effective corrective actions.
- Coordinate with international sites (Canada, South Africa, EMEA) to ensure alignment with international standards.
What We're Looking For
- Extensive experience in medical device quality assurance with strong knowledge of ISO 13485 and 21 CFR Part 820.
- Proven leadership and people management skills; experience managing teams in manufacturing or quality environments.
- Ability to develop, implement, and monitor quality systems across multiple sites; strong analytical and problem-solving skills.
- Fluent in English and Dutch with excellent communication; willingness to work on-site 2-3 days per week in Maastricht.
- Bachelor’s Degree in Engineering, Quality Management, or related field; minimum of 7 years’ experience in quality assurance; prior management experience leading diverse teams.
Nice to Have
- Familiarity with risk management files and performance of quality audits.
- Experience harmonising quality systems across different regions.
- Knowledge of Oracle, statistical analysis software, or document control systems.
- Previous experience in the medical device industry beyond software products.
Compensation & Benefits
- Salary: $95,000 USD per year.
- On-site presence in Maastricht 2-3 days per week.
- Equal Opportunity Employer.