Senior Quality Assurance Specialist (Medical Devices)

Location: Utrecht, hybrid working wiht 3 days onsite
Direct perm contract, starting with 12 months

About the Opportunity

Our client is an international medical device company developing innovative technologies for spinal surgery. Due to continued growth, they are looking for an experienced Senior Quality Assurance Specialist to join their Quality Assurance team in the Netherlands.

This role focuses on maintaining and continuously improving the Quality Management System (QMS), ensuring compliance with global quality standards, and supporting product development and manufacturing within a regulated medical device environment.

The Role

Working within the Quality Assurance team, you will play a key role in maintaining regulatory compliance, supporting quality processes across the business, and driving continuous improvement. You'll collaborate closely with Supply Chain, Manufacturing, Regulatory Affairs, Product Development, and external suppliers to ensure products meet the highest quality standards.

Key Responsibilities

• Maintain and improve the Quality Management System (QMS) in line with ISO 13485, GMP, and FDA quality requirements.
• Prepare, review, and approve quality procedures and controlled documentation.
• Plan, perform, and report internal and supplier audits.
• Support supplier qualification and quality documentation reviews.
• Coordinate change control, deviations, CAPAs, and quality improvement initiatives.
• Support product development projects and risk management activities as the Quality representative.
• Assist with regulatory submissions and external audits by customers and regulatory authorities.
• Deliver QA training and provide guidance to cross-functional teams.

Requirements

Essential

• Bachelor's degree in Life Sciences, Biomedical Sciences, Engineering, Chemistry, or a related discipline.
• Relevant Quality Assurance experience within medical devices, pharmaceuticals, or biologics.
• Strong knowledge of ISO 13485, GMP, FDA Quality System Regulations (21 CFR 820), and quality management systems.
• Experience conducting internal and supplier audits.
• Excellent written and spoken English.
• Based in the Netherlands or eligible to work there.

Desirable

• Experience within cleanroom or regulated manufacturing environments.
• Knowledge of medical device and/or pharmaceutical regulatory frameworks.
• Experience supporting supplier quality, product development, and risk management activities.
• Strong project management and stakeholder management skills.

What's on Offer

• Join an innovative international medical device organisation.
• Play a key role in maintaining quality and regulatory compliance for life-changing healthcare products.
• Collaborative, cross-functional environment with opportunities for professional growth.
• Competitive salary and benefits package.
• Flexible working arrangements.
• Based in the Utrecht region.

If you're an experienced Quality Assurance professional looking to further your career within an innovative and highly regulated medical device environment, we'd love to hear from you.