Director, Process Compliance & Centers of Excellence

Job Description

The Director, Process Compliance & Centers of Excellence is responsible for spearheading the strategic development and deployment of robust enterprise quality controls and process improvements. They will lead organization-wide compliance initiatives, proactively drive integration of new tools and processes, and analyze data for trends and risks.

Your role:

• Drives strategic initiatives to elevate supplier quality standards, collaborating closely with cross-functional teams in Research & Development (R&D), manufacturing, and regulatory affairs to address process gaps and maintain superior quality benchmarks.
• Guides setup of acceptance activities, including transfer to manufacturing, resolves process deficiencies, and develops New Product Introduction (NPI) validations, process development, process controls, inspection plans, and control plans.
• Collaborates with the Quality Optimization team to integrate initiatives into site QMS processes.
• Analyzes data to identify trends, risks, and improvement opportunities and proactively supports process improvement.
• Drives cost reduction and productivity through analysis of Cost of Poor Quality (COPQ) data and assists teams with implementation of cost-saving initiatives.
• Manages compliance with industry regulations and oversees the preparation and maintenance of documentation.
• Leads talent management and succession planning and develops a high-performing team aligned with organizational goals.
• Authorizes the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
• Mentors and cultivates a culture of continuous learning and knowledge sharing among quality engineers, ensuring effective support for New Product Introduction (NPI) projects and seamless product transfers within the manufacturing facility.
• Possesses expert knowledge of products/services and advanced quality engineering techniques, recognized as an expert within the field, and frequently interacts with senior management on matters across several functional areas.
• Works on complex issues, drawing on an in-depth understanding of the organization to analyze situations effectively, actively contributing to the development of organizational objectives and principles.
• Possesses broad cross-functional experience, demonstrates leadership exposure in a technical capacity, and is familiar with project management practices.
• Leads succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development in alignment with organizational operational goals.

You're the right fit if:

• You have a minimum of 10+ years’ experience in FDA-regulated medical device environments, with extensive focus in QMS Compliance, CAPA process, Internal Audit, and process/continuous improvement.
• You have a minimum of 5+ years’ experience in functional/strategic leadership of quality teams/organizations within global, matrixed organizations.
• You have robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR, and other global medical device standards.
• You have detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis, and design transfer activities.
• You have extensive experience leading/supporting regulatory inspections (FDA, Notified Bodies).
• You have proven experience leading strategic process validation initiatives, CAPA processes, Non-Conformances (NC), and Quality Notifications (QN).
• You have a minimum of a Bachelor’s degree in Engineering, Life Sciences, or a related technical field; a Master’s degree is preferred (MBA, MS, or equivalent).
• You must be able to successfully perform the minimum physical, cognitive, and environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than apart. For office-based teams, this means working in person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at customers’ or suppliers’ locations.

This is an Office role.

About Philips:

Philips is a health technology company.

Additional Information:

• May travel up to 25% (Domestic & International)