Director, Quality Programs – PMO, Ambulatory Monitoring & Diagnostics

Philips

Philips health technology leader driving global medical-device quality programs. Overseeing QMS compliance, regulatory submissions, cross-functional execution, and manufacturing-site transformation.

Posted 8/21/2026full-timeLinwood • Arizona, Pennsylvania • 🇺🇸 United StatesLead💰 $162,000 - $270,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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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.

Highest-signal resume keywords

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

QMS ImplementationCAPA ProgramsChange ManagementProcess ControlsRegulatory SubmissionsAudit ProcessesRisk ManagementBudgetingResource AllocationPerformance Assessment

Soft Skills

CommunicationInfluencingRelationship BuildingFacilitation

Certifications & Qualifications

Lean/Six SigmaASQ-CQM

Industry Keywords

FDA RegulationsISO 13485EU-MDR21 CFR 820Medical Device CompliancePost-Market SurveillanceVigilance ReportingQuality ImprovementSuccession PlanningTalent Management

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Annual incentive bonus may be offered
Sales commission may be offered
Long-term incentives may be offered
Generous PTO
401k with up to 7% match
HSA with company contribution
Stock purchase plan
Education reimbursement
Up to 10% travel