Quality Engineer – Design Control

About the role

We are looking for a Quality Engineer to support and coordinate Design Control activities throughout the product lifecycle. The role ensures that new product development and design changes follow established Design Control processes and that regulatory and contractual requirements are met.

Key responsibilities

• Lead design planning, requirements traceability, verification, validation, formal design reviews, design transfer, risk management and Design History File maintenance.
• Partner with cross‑functional teams to identify gaps, resolve issues and maintain compliance with medical‑device regulations.
• Verify contractual and regulatory requirements during tendering and project execution, and establish project quality plans, witness points and quality records.
• Incorporate customer feedback, FOE and lessons‑learned into future proposals to improve execution processes.
• Act as a resource for less‑experienced colleagues, lead local improvement projects and contribute to global quality initiatives.

Required profile

• 3‑5 years of Quality Engineering experience in a medical‑device environment.
• Education equivalent to a Bachelor’s degree in a relevant field (or high‑school diploma with comparable experience).
• Strong analytical thinking, ability to work with some autonomy and to propose solutions within defined standards.
• Excellent oral and written communication, problem‑solving and project‑management skills.

Required skills

• Design Control processes (planning, traceability, verification, validation).
• Risk Management and Design History File management.
• Regulatory compliance for medical devices.
• Project quality planning and execution.