Director of Quality & Process Excellence

Philips; Best; On-site; EUR 120,000 - 180,000; Full time

Job summary

Philips is seeking a Director of Process Compliance & Centers of Excellence to lead enterprise quality controls and process improvements. You will drive supplier quality initiatives, guide NPI validations, and oversee PFMEA, CAPA, and design transfer activities.

You will mentor a high-performing team, interact with senior management, and ensure regulatory compliance across FDA and global standards. Travel up to 25% may be required, and this is an office-based role.

Qualifications

• 10+ years in FDA-regulated medical devices focusing on QMS compliance and CAPA.
• 5+ years in leadership of quality teams in global matrix organizations.
• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and related standards.
• Expertise in Risk Management (ISO 14971), PFMEA, RCA, and design transfer.
• Experience leading regulatory inspections (FDA, Notified Bodies).

Responsibilities

• Lead strategic quality initiatives across supplier quality, R&D, manufacturing, and regulatory affairs.
• Oversee PFMEA assessments and design transfers for NPI and product transfers.
• Drive COPQ reductions and cost-saving through data trends and monitoring.
• Manage compliance with industry regulations and maintain documentation.
• Mentor quality engineers and manage talent development and succession planning.

Skills

Quality leadership

Data analysis

PFMEA knowledge

CAPA processes

Regulatory inspections experience

Risk management (ISO 14971)

Education

Bachelor's degree in Engineering or Life Sciences

Master’s degree preferred (MBA, MS, or equivalent)

Tools

QMS software

PFMEA tools

CAPA systems

Regulatory readiness tools

Job description

Philips is seeking a Director of Process Compliance & Centers of Excellence to lead enterprise quality controls and process improvements. You will drive supplier quality initiatives, guide NPI validations, and oversee PFMEA, CAPA, and design transfer activities.

You will mentor a high-performing team, interact with senior management, and ensure regulatory compliance across FDA and global standards. Travel up to 25% may be required, and this is an office-based role.