Director, Quality & Process Excellence

Philips Iberica SAU; Netherlands; Remote; EUR 93,000 - 155,000; Full time

Job summary

Philips seeks a Director to lead Process Compliance & Centers of Excellence, driving enterprise quality controls and process improvements across the organization. You will guide NPI validations, PFMEA reviews, and design transfer activities while mentoring a high-performing team.

Required 10+ years in FDA-regulated environments, strong leadership, and deep knowledge of ISO 13485, 21 CFR Part 820, and risk management. Office-based with travel up to 25% is expected.

Qualifications

• Bachelor's degree required in Engineering or Life Sciences.
• MBA or equivalent master's degree preferred.
• Extensive experience in FDA regulated medical devices and QMS compliance.
• Leadership of quality teams in global, matrixed organizations.

Responsibilities

• Lead organization-wide compliance initiatives and drive integration of new tools and processes.
• Guide acceptance activities, transfer to manufacturing, and NPI validations.
• Collaborate with Quality Optimization to align with site QMS processes.
• Analyze data for trends, risks, and opportunities to improve processes.
• Drive COPQ reduction and support cost-saving initiatives.
• Manage compliance with industry regulations and maintain documentation.
• Mentor and develop a high-performing quality team.

Skills

Quality leadership

Regulatory compliance

FDA 21 CFR Part 820

ISO 13485

PFMEA

Risk management

Design transfer

CAPA

Project management

People management

Education

Bachelor's degree in Engineering/Life Sciences

Tools

QMS software

Job description

Philips seeks a Director to lead Process Compliance & Centers of Excellence, driving enterprise quality controls and process improvements across the organization. You will guide NPI validations, PFMEA reviews, and design transfer activities while mentoring a high-performing team.

Required 10+ years in FDA-regulated environments, strong leadership, and deep knowledge of ISO 13485, 21 CFR Part 820, and risk management. Office-based with travel up to 25% is expected.