Quality Engineer – New Product Development

About the role

As a Quality Engineer in New Product Development, you will ensure that innovative healthcare products and manufacturing processes meet the highest standards of safety, quality and regulatory compliance. You will work closely with project managers, engineers, operations and validation teams to embed quality throughout the product lifecycle.

Key responsibilities

• Represent quality within cross‑functional NPI projects and drive quality excellence.
• Define and support validation strategies, including IQ, OQ, PQ and PPQ.
• Lead risk assessments such as FMEA and oversee contamination‑control activities.
• Maintain GMP compliance and ensure inspection readiness.
• Integrate NPI activities into quality systems (change control, CAPA, deviations).
• Support engineering runs, validation batches, technology transfers, scale‑up and commercial launches.

Required profile

• Master’s degree in Engineering, Chemistry, Life Sciences or a related field.
• 5‑8 years of experience in medical devices, pharmaceuticals or another highly regulated industry.
• Strong knowledge of GMP requirements, validation and risk management.
• Excellent stakeholder management and fluent English communication skills.

Required skills

• IQ/OQ/PQ/PPQ validation protocols
• Failure Mode and Effects Analysis (FMEA)
• Good Manufacturing Practice (GMP) and EU GMP
• Annex 1, FDA regulations, ISO 13485, ISO 14971
• Risk management and contamination‑control techniques

What we offer

• Competitive compensation package.
• Hybrid working model to support work‑life balance.
• Continuous learning and development opportunities.
• Collaborative, high‑performing team environment.