Quality Assurance Manager Europe | Medical Devices in Tilburg

Lead Quality Assurance across a complex European distribution network
Drive compliance, operational excellence and continuous improvement in MedTech
About Our Client Our client is a global healthcare manufacturer with a long-standing reputation for innovation, patient focus and regulatory excellence. With products distributed across more than 90 countries, quality is at the heart of every operational decision.
The European Distribution Centre serves as a critical hub within the organisation's global supply chain and plays a vital role in ensuring product availability, regulatory compliance and customer satisfaction throughout Europe.
Job Description As a member of both the Global Quality Leadership Team and the European Distribution Centre Leadership Team, you will provide strategic and operational leadership for all Quality Assurance activities related to European distribution operations. You will champion a proactive culture of quality while ensuring the organisation remains inspection-ready and compliant with evolving regulatory requirements.
Lead, develop and mentor a team of Quality Assurance professionals, establishing clear objectives, succession planning and professional development programmes
Own the Quality Management System for the European Distribution Centre and provide quality oversight of external logistics partners, including 3PL and 4PL providers across Europe
Define and execute the quality strategy for European distribution activities, ensuring alignment with global quality objectives and business priorities
Ensure ongoing compliance with ISO 13485, ISO 14971, MDR, MDD, applicable FDA requirements and Good Distribution Practices (GDP)
Act as the quality representative during Notified Body, regulatory authority and customer audits, driving successful inspection outcomes and timely remediation of findings
Provide quality oversight of change control, CAPA management, non-conformance investigations, complaint handling, risk management and internal audit programmes
Maintain oversight of finished goods release activities and support quality decision-making related to product disposition where applicable
Assess and approve quality requirements associated with product transfers, product lifecycle changes and the introduction of new products into the European market
Drive root cause investigations and continuous improvement initiatives, leveraging data analysis, quality metrics and risk-based decision-making
Partner with Supply Chain, Operations, Regulatory Affairs and Commercial teams to ensure robust quality processes throughout the distribution network
Manage departmental budgets, resource planning and quality performance indicators to support operational and strategic objectives
The Successful Applicant You are an experienced Quality leader who combines deep regulatory expertise with strong people leadership skills. You have successfully managed Quality Systems within highly regulated medical device or pharmaceutical environments and are comfortable operating in a matrix organisation with significant stakeholder exposure.
You bring a proactive approach to compliance, a passion for continuous improvement and the credibility to influence both operational and executive-level decision-making.
Bachelor's or Master's degree in Quality, Life Sciences, Engineering, Supply Chain, Pharmacy or a related scientific discipline
Minimum 8 years of experience within Medical Devices, Pharmaceuticals or another highly regulated healthcare environment
Minimum 5 years of leadership experience with direct responsibility for Quality teams and Quality Systems
Proven expertise in ISO 13485, ISO 14971, MDR, MDD and quality system regulations governing medical device distribution
Demonstrated experience leading external audits and serving as primary contact for regulatory authorities and Notified Bodies
Strong knowledge of GDP, supplier quality management and distribution quality oversight
Experience managing CAPA systems, risk management processes and complex compliance investigations
Track record of successfully implementing quality improvements and driving operational excellence initiatives
Strong analytical skills with the ability to interpret quality trends, performance metrics and compliance data
Excellent stakeholder management and communication skills, with the ability to influence across all organisational levels
Fluent English language skills, both written and verbal
What's on Offer Competitive base salary aligned with senior Quality leadership positions within the Medical Device industry
Annual performance bonus and comprehensive benefits package
Significant visibility within global Quality and Supply Chain leadership teams
Opportunity to influence quality strategy across multiple European markets
Direct participation in international leadership forums and global quality initiatives
Exposure to regulatory inspections, strategic business projects and organisational transformation programmes
Clear opportunities for long-term career progression within a global healthcare organisation
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