Design Quality Engineer

About the role

As a Design Quality Engineer you will ensure that new medical device products meet all regulatory and internal quality requirements. You will support New Product Development (NPD) and New Product Introduction (NPI) initiatives, working closely with R&D, engineering and cross‑functional teams.

Key responsibilities

• Manage Quality Engineering resources for NPD/NPI projects.
• Provide expert support for design, process, equipment and software validation activities.
• Facilitate risk management processes, maintain risk files and support post‑market surveillance.
• Collaborate with R&D and Engineering to deliver robust product launches and lifecycle management.
• Review and approve validation documentation, participate in internal and external audits, and support regulatory submissions.
• Drive a culture of quality and continuous improvement across the organization.

Required profile

• Third‑level degree in Engineering, Science or a related discipline.
• Minimum 3 + years experience with Class II or III medical devices.
• Experience in a regulated medical device, pharmaceutical or life‑sciences environment.
• Strong knowledge of QSR, ISO 13485, ISO 14971, MDD/MDR, MDSAP, 21 CFR and ICH guidelines.
• Hands‑on experience with design, process, equipment and software validation.
• Proven ability to manage complexity, prioritize tasks and lead cross‑functional teams.

Required skills

• QSR (Quality System Regulation)
• ISO 13485
• ISO 14971
• MDD/MDR
• MDSAP
• 21 CFR
• ICH guidelines
• Design validation
• Process validation
• Equipment validation
• Risk management
• Root cause analysis
• Statistics
• Process capability

What we offer

• Competitive salary and benefits package with clear progression routes.
• Exposure to innovative projects and regulatory complexity.
• Multidisciplinary teamwork in a supportive work culture.
• Opportunities for continuous learning, development and improvement.