Senior Manager, Quality Engineering

About the role

West is seeking a senior leader to head Quality Engineering, Manufacturing Quality and Quality Compliance across its sites. The role combines oversight of design transfer, process validation, production quality and post‑market surveillance, while supporting a culture of continuous improvement.

Key responsibilities

• Lead review and approval of technical documentation such as DMR, DHF, IQ/OQ/PQ, process validations and risk management files (dFMEA/pFMEA).
• Provide quality oversight for new production line establishment, engineering changes, software validations and raw material approvals.
• Manage production quality controls including calibration, DHR/batch record review, labeling release and non‑conformance management.
• Drive Right First Time and Cost of Poor Quality initiatives.
• Lead customer complaint handling and post‑market surveillance activities.
• Collaborate cross‑functionally with Operations, Engineering, Regulatory Affairs, Supply Chain and external stakeholders to ensure compliance with ISO 13485, MDR 2017/745, MDSAP, ISO 14971, 21 CFR 820 and GMP requirements.

Required profile

• Extensive experience in quality engineering and compliance within medical device or pharmaceutical manufacturing.
• Proven leadership of multidisciplinary quality teams.
• Strong understanding of regulatory standards and risk‑based quality systems.
• Excellent problem‑solving and escalation support skills.

Required skills

• ISO 13485
• MDR 2017/745
• MDSAP
• ISO 14971
• 21 CFR 820
• GMP
• FMEA (dFMEA/pFMEA)
• IQ/OQ/PQ
• Process validation

What we offer

• Inclusive community with lifelong learning and development opportunities.
• Comprehensive benefit programs supporting physical, mental, emotional and financial health.
• Commitment to sustainability and community involvement.