Quality Assurance Manager Europe | Medical Devices

Michael Page (Netherlands); Noord-Brabant; On-site; EUR 120,000 - 170,000; Full time

Benefits offered by this job

Competitive base salary

Annual performance bonus

Comprehensive benefits package

Global leadership exposure

Job summary

Michael Page (Netherlands) represents a global healthcare manufacturer seeking a Quality Leader to steer European distribution QA. You will head the QA function, ensuring regulatory readiness and overseeing external partners across Europe.

The role requires deep regulatory expertise, strategic leadership and a proactive culture of quality, with accountability for compliant operations and continuous improvement across the distribution network.

Qualifications

• Regulated healthcare environment experience (Medical Devices/Pharma)
• Proven leadership of Quality Systems and teams
• Experience with external audits and regulatory interactions
• Strong understanding of GDP, ISO 13485, ISO 14971, MDR/MDD

Responsibilities

• Lead and mentor QA professionals with clear objectives and development plans
• Own the European Distribution Centre Quality Management System and oversee 3PL/4PL partners
• Define and execute European quality strategy aligned with global objectives
• Ensure compliance with ISO 13485, ISO 14971, MDR/MDD and GDP principles
• Represent quality during Notified Body/regulatory audits and drive remediation of findings
• Oversee CAPA, change control, risk management, investigations and internal audits
• Approve product transfers, lifecycle changes and new product introductions in Europe
• Drive root cause investigations and continuous improvement using data and metrics
• Collaborate with Supply Chain, Operations, Regulatory Affairs and Commercial teams
• Manage departmental budgets, resources and quality performance indicators

Skills

Quality leadership

Regulatory expertise

Stakeholder management

Audits & regulatory bodies

CAPA & root cause analysis

Risk management & metrics

Data analytics

Communication skills

Education

Bachelor's or Master's in Quality/Life Sciences/Engineering/Supply Chain/Pharmacy

Tools

GDP knowledge

Job description

• 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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