Quality Assurance Manager

Role: QA Manager – Design Controls

 

We are partnering with a global Medical Device company seeking a QA Manager specializing in Design Controls. This is a strategic leadership opportunity to ensure compliance in product development, risk management, and quality assurance processes while driving cross-functional

collaboration to bring high-quality medical devices to market.

? Location: Utrecht – Hybrid

? Scope: Design Quality & Compliance

 

The Role

As a QA Manager, you will oversee design control activities, risk management, and regulatory compliance for finished medical devices. You will lead quality assurance initiatives, mentor a QA team, and drive process improvements to enhance efficiency and compliance with ISO 13485, MDR 2017/745, PPE, and other applicable regulations.

 

Key Responsibilities

• Oversee design control activities, ensuring compliance with ISO 13485, MDR, PPE, and ISO 14971 risk management, integrating them into product development.
• Manage design history files (DHFs) and ensure robust documentation across design reviews, verification, validation, and design transfer.
• Supervise product testing and ensure compliance with EU regulatory requirements.
• Lead, mentor, and develop the QA team, fostering a culture of quality and driving continuous improvement initiatives.
• Develop and track quality metrics, reporting to senior management while ensuring alignment with corporate and regulatory standards.
• Support internal/external audits, CAPA management, and regulatory compliance, collaborating with Regulatory Affairs on EU requirements.
• Investigate defective product trends and customer complaints, coordinating supplier quality management and decision-making on deviations.
• Provide QA support for EU market tenders and product management.

 

Qualifications & Experience

• Degree in Life Sciences (Biology, Chemistry) or Engineering with 6+ years of experience in the Medical Device industry.
• Strong knowledge of ISO 13485, MDR 2017/745, and related regulations.
• Expertise in design controls, risk management, and regulatory compliance.
• Track record in leading and developing a QA team.
• Strong leadership, communication, and problem-solving skills.
• Ability to manage complex quality operations in a fast-paced environment.
• Fluent in English; French is a plus.
• Frequent travel to France is required.

 

Why Join?

Be part of a leading Medical Device company, driving quality assurance and regulatory compliance in a highly innovative sector. This role offers the opportunity to lead a team, implement quality improvements, and enhance global market access for medical technologies.

 

How to Apply

If you are an experienced QA Manager with expertise in design controls and regulatory compliance within MedTech, Life Sciences, or Pharmaceuticals, we’d love to hear from you!

 

? Apply now or contact Aimee Brenner at a.brenner@panda-int.com for more information.