Head of Quality, Ambulatory Monitoring & Diagnostics

Philips
Cambridge
Workplace: HybridFull timeUSD 205,000 - 349,440 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 15+ yearsEducation: bachelorsSkills: ["Leadership","Strategic thinking","Communication","Relationship building","Cross-functional collaboration"]

Lead the global quality vision and strategy for Ambulatory Monitoring & Diagnostics, driving product safety, regulatory compliance, and operational excellence across FDA-regulated medical devices and EU MDR requirements. Define and execute the global Quality strategy for products, software, services, and sites, oversee the QMS and post-market surveillance, and serve as Management Representative and primary interface with regulatory authorities. Build and lead a global quality team while partnering cross-functionally to standardize processes and enable continuous improvement.

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Philips
Philips
14 hours ago

Head of Quality, Ambulatory Monitoring & Diagnostics

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Last checked: 14 hours agoStatus: Live

Job Summary

Lead the global quality vision and strategy for Ambulatory Monitoring & Diagnostics, driving product safety, regulatory compliance, and operational excellence across FDA-regulated medical devices and EU MDR requirements. Define and execute the global Quality strategy for products, software, services, and sites, oversee the QMS and post-market surveillance, and serve as Management Representative and primary interface with regulatory authorities. Build and lead a global quality team while partnering cross-functionally to standardize processes and enable continuous improvement.
Location: Cambridge
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Sr. Director level

Key Responsibilities

  • •Lead the global Quality strategy to ensure product safety, regulatory compliance, and alignment with business growth objectives.
  • •Define and execute a forward-looking global Quality strategy across products, software, services, sites, and operations.
  • •Ensure compliance and inspection readiness across FDA, EU MDR, ISO 13485, 21 CFR 820, and other international requirements.
  • •Serve as Management Representative and primary interface with regulatory authorities, and oversee the QMS, regulatory submissions, post-market surveillance, and lifecycle compliance.
  • •Lead and develop a global team, including planning, talent/succession, staffing, budgeting, performance management, and capability development.

Pay and Benefits

Salary: USD 205,000 - 349,440 annually
Equity and Bonus:Equity
Perks:Health Insurance401kHsaPaid LeaveLearning BudgetEquity

Key Requirements

  • •Bachelor's degree in Science, Engineering, or a similar technical discipline (Master's degree in business/management/quality strongly preferred).
  • •Minimum 15 years of global MedTech industry experience with progressive leadership.
  • •Leadership experience in quality areas including design quality, quality systems, post-market surveillance, and audit representation.
  • •Experience establishing and implementing quality strategy and systems for a multi-site, multi-national business.
  • •Relevant Continuous Improvement training/certification (Lean/Six Sigma) highly preferred.
Experience:15+ yearsMedTechMedical devicesRegulatory complianceMulti-siteGlobalQuality management systems
Education:Bachelor's in Science or Engineering (or similar technical discipline)
Skills:LeadershipStrategic thinkingCommunicationRelationship buildingCross-functional collaboration
Certifications:LeanSix Sigma
Tech Stack:ISO 1348521 CFR 820QMSPost-market surveillanceRegulatory submissionsLeanSix Sigma

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Philips
Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Amsterdam, Netherlands
Founded: 1891
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn