Quality Assurance Lead

Connecting Top QA/RA Talent with Leading MedTech Companies Recruitment International

Location: Gelderland area, Netherlands

Contract: 12-month temporary assignment (32-40 hours per week)

Department: Quality & Regulatory Affairs

We are partnering with a global medical technology organization recognized for its extensive product portfolio, robust supply chain network, and strong commitment to healthcare quality and sustainability. The company develops, manufactures, and distributes surgical and medical products across Europe, supporting healthcare providers in improving patient outcomes and operational performance.

About the Role

This temporary Quality Manager position is based at one of the company's key Dutch operations sites. You will oversee the Quality Management System (QMS) and ensure compliance with ISO 13485, EU MDR, and FDA standards. Acting as the quality representative for the site, you'll collaborate with cross-functional teams to support manufacturing, warehousing, and distribution activities for Class I and Class IIa medical devices.

Key Responsibilities

• Lead, maintain, and continuously improve the site's QMS in line with ISO 13485 and FDA.
• Manage departmental resources and budget while ensuring compliance with quality and regulatory standards.
• Support technical documentation and product registration processes.
• Coordinate internal audits, CAPA, risk management, and complaint investigations.
• Oversee product release and documentation control.
• Act as the main point of contact for external audits and inspections.
• Supervise and coach a small local Quality team.
• Drive quality awareness and improvement initiatives across the organization.

Qualifications

• Bachelor's degree or higher in Science, Engineering, or related discipline (HBO level or equivalent).
• 3-5 years of experience in medical device manufacturing or a similarly regulated environment.
• Strong knowledge of ISO 13485, MDR, and FDA.
• Experience with validation, complaint handling, and audit processes.
• Familiarity with sterilization processes and product manufacturing is an advantage.
• Excellent command of English; additional European languages (e.g., German or Dutch) are beneficial.

What's on Offer

• Competitive salary and annual bonus plan.
• 29 vacation days and flexible hybrid work arrangements.
• Professional training and personal development opportunities.
• International working environment with a strong culture of collaboration and inclusion.

To discuss this opportunity or express your interest, please send your CV to