Design Quality Engineer

Design Quality Engineer
Luxembourg (Hybrid)
Full-time, 40 hours per week
Medical Device Sector
Overview

Our client, a growing medical device manufacturer, is seeking a Design Quality Engineer to support product development activities and ensure compliance with applicable quality and regulatory requirements throughout the product lifecycle.Key Responsibilities

• Act as the Quality representative within cross-functional product development projects.
• Ensure compliance with ISO 13485, MDR (EU 2017/745), and internal quality management system requirements.
• Support Design Control activities including design planning, design reviews, verification, validation, and design transfer.
• Review and approve design documentation, risk management files, and technical documentation.
• Participate in DFMEA, risk assessments, CAPAs, non-conformance investigations, and change control activities.
• Support internal and external audits, including notified body inspections.
• Collaborate closely with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality teams.
• Ensure products are developed and maintained in compliance with applicable regulatory requirements.

Requirements

• Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
• 3+ years of experience in a Design Quality or Quality Engineering role within the medical device industry.
• Strong knowledge of Design Controls, Risk Management (ISO 14971), and ISO 13485.
• Experience supporting product development from concept through commercialisation.
• Familiarity with EU MDR requirements.
• Excellent communication skills in English. French is advantageous.

What's on Offer

• Hybrid working model.
• International and collaborative environment.
• Opportunity to support innovative medical device development projects.
• Competitive salary and benefits package.

If you're interested in learning more, please get in touch to discuss the opportunity in confidence.