Quality Assurance Manager

Quality Assurance Manager

Planet Pharma

Maastricht, Netherlands

Are you a seasoned quality professional with a passion for elevating standards in the medical device industry? We’re seeking an innovative and detail-oriented Quality Assurance Manager to lead our quality team in Maastricht. This is a unique opportunity to shape quality initiatives across multiple regions, including Canada, South Africa, and EMEA, in a dynamic and growing environment. As the key figure overseeing product quality and harmonisation of our Quality Management System, you will play a pivotal role in ensuring our manufacturing processes meet the highest standards. Reporting directly to the Senior Director of Quality and managing a team of seven, including two direct reports, you will be instrumental in maintaining our reputation for quality and compliance.

Required Skills:

• Extensive experience in medical device quality assurance, with strong knowledge of ISO 13485 and 21CFR Part 820 regulations;
• Proven leadership and people management skills, with experience managing teams in a manufacturing or quality environment;
• Demonstrated ability to develop, implement, and monitor quality systems across multiple sites;
• Exceptional analytical and problem-solving skills, with a keen eye for detail;
• Fluent in English and Dutch, with excellent communication skills;
• Willingness to work on-site 2-3 days per week in Maastricht.

Nice to Have Skills:

• Familiarity with risk management files and performance of quality audits;
• Experience with harmonising quality systems across different regions;
• Knowledge of software tools such as Oracle, statistical analysis software, or document control systems;
• Previous experience working within the medical device industry beyond software products.

Preferred Education and Experience:

• Bachelor’s Degree in Engineering, Quality Management, or related field;
• Minimum of 7 years’ experience in quality assurance, preferably within the medical device industry;
• Prior management experience leading diverse teams.

Other Requirements:

• On-site presence in Maastricht 2-3 days per week;
• Ability to coordinate with global teams and ensure compliance with international standards;
• Strong organizational skills and the ability to handle multiple priorities effectively.