Senior Quality Engineer

Walker Cole International is supporting a leading medical device manufacturer in the search for a Senior Quality Engineer to join their site in Catalonia, Spain.

This is a senior quality leadership role responsible for production, microfabrication and final quality control activities, ensuring manufacturing processes are controlled, compliant and capable of consistently delivering safe, high-quality medical devices. The successful candidate will act as a key technical partner to Manufacturing, Microfabrication and QARA, owning complex production quality workstreams from equipment qualification through to nonconformity investigation and CAPA.

Your Responsibilities as Senior Quality Engineer 

• Own and continuously improve production and microfabrication quality controls, ensuring alignment with SOPs, specifications, control plans and PFMEAs.
• Lead process and test method validation, equipment qualification, and quality oversight of facility, cleanroom and critical production equipment.
• Lead complex nonconformity and quality investigations across production, equipment, cleanroom activities and suppliers, driving root-cause analysis and CAPA to closure.
• Own production quality performance indicators and provide technical coaching to Quality Engineers and manufacturing personnel.

Your Background as Senior Quality Engineer 

• Degree-qualified in Biomedical Engineering, Materials Science, Micro/Nanotechnology or a related technical discipline, with 5+ years' quality engineering experience in a regulated manufacturing environment, ideally medical devices.
• Strong experience with process validation, equipment qualification and manufacturing process controls, with working knowledge of ISO 13485.
• Proven track record leading nonconformity investigations, root-cause analysis, CAPA and effectiveness verification within a GMP-like or regulated environment.
• Demonstrated ability to work cross-functionally with Manufacturing, Development, Supply Chain and external suppliers/CMOs, with the assertiveness to escalate or contain activities where compliance is at risk.

Senior Quality Engineer | Quality Engineering | Production Quality | Medical Devices | Microfabrication | ISO 13485 | Process Validation | Equipment Qualification | CAPA | Root Cause Analysis | Nonconformity Investigation | Cleanroom | Contamination Control | EU MDR | FDA 21 CFR 820 | Supplier Quality | CMO Quality Oversight | Manufacturing Engineering | Quality Assurance | GMP

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