European Quality Assurance Leader - MedTech & Distribution

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

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.