Quality Assurance Engineer Utrecht • Panda International

Role: QA Engineer – Design Controls

We are partnering with a global Medical Device company seeking a QA Engineer specializing in Design Controls. This is a unique opportunity to ensure compliance in product development, drive regulatory alignment, and support market access for innovative medical devices.

Location: Utrecht – Two days per week onsite 

Scope: Product Development & Design Compliance

The Role

As a QA Engineer, you will ensure design quality and regulatory compliance in product development and design changes. You will collaborate with cross-functional teams, manage design control activities, and support the launch of new products while maintaining robust design history files (DHFs) in alignment with ISO 13485, MDR 2017/745, PPE, and cosmetics regulations.

Key Responsibilities

• Manage new product launches and design change projects, ensuring compliance and timely market access.
• Ensure design control activities meet ISO 13485, MDR 2017/745, and other regulatory standards.
• Oversee risk management (ISO 14971) and integrate it into the design process.
• Facilitate design reviews, verification, validation, and design transfer.
• Maintain design history files (DHFs) and support technical documentation.
• Work with Regulatory Affairs to ensure compliance with EU requirements.
• Coordinate product inspections, lab testing, and quality assessments.
• Investigate customer complaints and drive corrective actions with suppliers.
• Support process validation (IQ, OQ, PQ) and internal/external audits.
• Collaborate with suppliers to enhance quality and CAPA management.
• Provide QA support for EU market tenders and product management.

Qualifications & Experience

• Degree in Life Sciences (Biology, Chemistry) or Engineering.
• 4+ years of experience in the Medical Device industry.
• Strong knowledge of ISO 13485, MDR 2017/745, and regulatory requirements.
• Expertise in design controls, risk management, and regulatory compliance.
• Analytical mindset with problem-solving & decision-making skills.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook).
• Ability to thrive in a fast-paced environment and manage multiple projects.
• Fluent in English; additional languages are a plus.

Why Join?

Be part of a leading Medical Device company driving innovation in product development and regulatory compliance. This role offers the opportunity to impact global market access, ensuring product safety and effectiveness in a highly regulated industry.

How to Apply

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

Apply now or contact Aimee Brenner at via de button "Solliciteer nu" op deze pagina. for more information.