Device Quality Engineer

About the role

GXP Consulting Switzerland is expanding its MedTech & Combination Products team and seeks a Device Quality Engineer to lead design control and quality oversight for drug‑device projects such as autoinjectors and prefilled syringes.

Key responsibilities

• Act as quality owner of design control activities, ensuring compliance with 21 CFR 820/QMSR, 21 CFR Part 4, ISO 13485 and EU MDR Art. 117.
• Review and approve Design History File deliverables, including design plans, inputs, specifications, traceability matrices, verification/validation protocols and reports.
• Participate in design reviews as the independent quality reviewer and verify phase‑gate deliverables.
• Ensure design outputs are transferred into the Device Master Record and manufacturing documentation.

Required profile

• Master’s degree in Engineering, Life Sciences or equivalent.
• 5+ years of experience in device quality within a GMP/QMS environment, preferably on combination products.
• Strong knowledge of ISO 13485, ISO 11608, MDR and FDA design‑control requirements.
• Fluent English; French or German is an asset.

Required skills

• ISO 13485
• ISO 11608
• EU MDR
• 21 CFR 820 / QMSR
• FMEA
• Change control
• Investigations and CAPA

What we offer

• Human‑sized company with diverse, supportive colleagues.
• Opportunities to work on ambitious international projects.
• Continuous learning through internal and external training.
• Competitive salary package and exceptional employment benefits.