Director, Process Excellence & Compliance

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

Job summary

Philips is seeking a Director of Process Compliance & Centers of Excellence to lead enterprise quality controls, drive process improvements, and oversee regulatory compliance across global operations. You will guide PFMEA, CAPA, and NPI validations while partnering with R&D, manufacturing, and regulatory affairs to maintain top-quality standards.

You will manage a high-performing team, drive cost reduction through COPQ data, and influence design transfers with senior leadership.

Qualifications

• 10+ years in FDA regulated medical device environments with QMS compliance focus.
• 5+ years in leadership of quality teams in global matrixed structures.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and related standards.

Responsibilities

• Lead strategic initiatives to improve supplier quality and compliance.
• Guide acceptance activities and transfer to manufacturing for NPI validations and process development.
• Collaborate across R&D, manufacturing, and regulatory affairs on process gaps.
• Mentor quality engineers and drive talent management and succession planning.
• Manage PFMEA and controls related to design changes and process transfers.

Skills

Leadership

Strategic planning

Quality systems

Data analysis

Risk management

Project management

Education

Bachelor's degree in Engineering/Life Sciences

Master’s degree preferred (MBA/MS)

Tools

PFMEA

CAPA system

Job description

Philips is seeking a Director of Process Compliance & Centers of Excellence to lead enterprise quality controls, drive process improvements, and oversee regulatory compliance across global operations. You will guide PFMEA, CAPA, and NPI validations while partnering with R&D, manufacturing, and regulatory affairs to maintain top-quality standards.

You will manage a high-performing team, drive cost reduction through COPQ data, and influence design transfers with senior leadership.