Director, Quality Programs – PMO, Ambulatory Monitoring & Diagnostics

• Provide strategic leadership and execute the global quality vision
• Lead critical quality, compliance, QMS implementation, PQMS transition, and continuous improvement programs
• Coordinate activities across multiple disciplines and align programs with business objectives and regulatory requirements
• Guide managers and identify opportunities for quality improvement and innovation
• Analyze complex organizational issues and contribute to objectives and principles
• Oversee regulatory submissions and product compliance with FDA, EU-MDR, ISO 13485, 21 CFR 820, and other requirements
• Harmonize regulatory processes across functions and establish management review processes
• Support succession planning and talent management, including employee selection, performance, compensation, and career development
• Interact with executive-level management and oversee planning, staffing, budgeting, expense priorities, and methodological changes
• Potentially perform PRRC responsibilities, including device compliance verification, technical documentation, post-market surveillance, and vigilance reporting
• Plan, manage, execute, and ensure program timeliness across manufacturing sites and Philips entities
• Determine, achieve, and communicate program objectives; facilitate cross-functional integration; coordinate logistics; and adhere to budgets
• Manage and facilitate FDA, competent authority, regulatory agency, and notified body audits and inspections

• Minimum of 10+ years’ experience leading full-cycle, global Quality Programs within FDA-regulated medical device manufacturing/supply chain environments
• 5+ years in strategic/cross-functional leadership
• Experience with Quality Management Systems (QMS), including ISO 13485 QMS implementation/transitions, CAPA, nonconformance, and process controls
• Experience with E2E global program management, change/risk management, KPIs, budgeting, timelines, resource allocation, strategy, reporting, and communication
• Experience leading and implementing QMS processes and tools, change/management controls, training programs, audit/non-conformance processes, CAPA programs, and systemic improvements
• Detailed knowledge of medical device regulations and standards, including 21 CFR Parts 803, 806, and 820; ISO 13485; ISO 14971;
  European Medical Device Directive 93/42/EEC; EU Medical Device Regulation; and Canadian Medical Devices Regulation SOR/98-282
• Experience utilizing data analytics and quality KPIs to assess performance and identify improvement and remediation opportunities
• Ability to communicate, influence, build relationships, and facilitate regulatory audits and inspections
• Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical field
• Lean/Six Sigma and ASQ-CQM certifications desired
• US work authorization required; visa sponsorship unavailable
• Must reside in or within commuting distance to Linwood, PA or Phoenix, AZ
• Ability to perform minimum physical, cognitive, and environmental requirements with or without accommodation

Demonstrates extensive experience in leading global Quality Programs within FDA-regulated medical device environments, with a strong focus on Quality Management Systems (QMS) implementation, regulatory compliance, and continuous improvement initiatives. Proven ability to manage cross-functional teams, drive strategic objectives, and facilitate regulatory audits and inspections.

• Global Quality Program Leadership
• Quality Management Systems (QMS)
• Regulatory Compliance (FDA, ISO 13485)
• Data Analytics and Quality KPIs
• Strategic Cross-Functional Leadership

• QMS Implementation
• CAPA Programs
• Change Management
• Process Controls
• Regulatory Submissions
• Audit Processes
• Risk Management
• Budgeting
• Resource Allocation
• Performance Assessment

• Communication
• Influencing
• Relationship Building
• Facilitation

• Lean/Six Sigma
• ASQ-CQM

• FDA Regulations
• ISO 13485
• EU-MDR
• 21 CFR 820
• Medical Device Compliance
• Post-Market Surveillance
• Vigilance Reporting
• Quality Improvement
• Succession Planning
• Talent Management