Director, Process Compliance & Centers of Excellence

About the role

The Director, Process Compliance & Centers of Excellence will lead the strategic development and deployment of enterprise‑wide quality controls and process improvements. This role drives organization‑wide compliance initiatives, integrates new tools and processes, and uses data analysis to identify trends and risks.

Key responsibilities

• Lead strategic initiatives to raise supplier quality standards and collaborate with R&D, manufacturing, and regulatory affairs to close process gaps.
• Guide acceptance activities, NPI validations, process development, inspection plans and control plans.
• Integrate quality optimization initiatives into the site QMS and analyze data for improvement opportunities.
• Drive cost reduction through Cost of Poor Quality analysis and support implementation of savings projects.
• Oversee regulatory compliance, documentation preparation, and internal audit readiness.
• Manage talent, succession planning and develop a high‑performing quality engineering team.

Required profile

• 10+ years experience in FDA‑regulated medical device environments with deep QMS, CAPA and internal audit expertise.
• 5+ years of functional/strategic leadership of quality teams in global, matrixed organisations.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and ISO 14971.
• Proven track record leading regulatory inspections and strategic process validation initiatives.
• Bachelor’s degree in Engineering, Life Sciences or related field; Master’s preferred.

Required skills

• FDA 21 CFR Part 820
• ISO 13485
• EU MDR
• ISO 14971 (Risk Management)
• PFMEA
• CAPA
• Root Cause Analysis
• Design Transfer
• Internal Audit
• Regulatory Inspection
• Cost of Poor Quality analysis
• Quality Management System (QMS) compliance

What we offer

• Base salary range €93,000 – €155,000 per year.
• Hybrid office work with a minimum of three days on‑site per week.