Director of Quality Excellence & Compliance

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

Job summary

Philips International, a health-technology leader based in the Netherlands, seeks a Director, Process Compliance & Centers of Excellence to lead enterprise quality controls, PFMEA, and process improvements across R&D, manufacturing, and regulatory affairs. This role drives NPI validations, design transfer, and cost-reduction initiatives while shaping a high-performing quality organization.

The position requires 10+ years in FDA-regulated environments, 5+ years in strategic leadership within

Qualifications

• 10+ years’ experience in FDA regulated medical device environments, with extensive focus in QMS Compliance, CAPA, Internal Audit and process improvement.
• 5+ years’ experience in functional/strategic leadership of quality teams in global, matrixed organizations.
• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical device standards.
• Detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
• Extensive experience leading/regulatory inspections (FDA, Notified Bodies).
• Experience leading strategic process validation initiatives, CAPA, NC and Quality Notifications (QN).
• Bachelor’s degree in Engineering, Life Sciences, or related field; Master’s preferred (MBA, MS).
• Ability to meet physical, cognitive, and environmental requirements of the role.

Responsibilities

• Spearhead strategic development and deployment of enterprise quality controls and process improvements.
• Lead organization-wide compliance initiatives and integrate new tools and processes.
• Analyze data for trends, risks and improvement opportunities; drive COPQ-based cost savings.
• Guide transfer to manufacturing, NPI validations, process development and control plans.
• Mentor quality engineers and support NPI projects and product transfers.
• Ensure compliance with global regulations and maintain documentation; manage succession planning and talent development.

Job description

Philips International, a health-technology leader based in the Netherlands, seeks a Director, Process Compliance & Centers of Excellence to lead enterprise quality controls, PFMEA, and process improvements across R&D, manufacturing, and regulatory affairs. This role drives NPI validations, design transfer, and cost-reduction initiatives while shaping a high-performing quality organization.

The position requires 10+ years in FDA-regulated environments, 5+ years in strategic leadership within