Senior Quality Manager-Advanced Imaging

Philips
United States
Workplace: HybridFull timeUSD 134,000 - 213,000 annuallyFunction: Quality & Regulatory (Non-Software)Education: bachelorsSkills: ["Leadership","Cross-functional collaboration","Data-based decision-making","Coaching","Risk management"]

Lead the Quality Management System (QMS) and Design Assurance for image guided therapy products across the full lifecycle. Ensure compliance with global regulations and standards (FDA QMSR, ISO 13485, EU MDR), manage audits/inspections as the primary quality representative, drive CAPA and nonconformance investigations, and use quality KPIs and risk management to improve product safety and performance. Partner cross-functionally with R&D, Operations, and Regulatory Affairs to execute quality strategy.

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FursaFursa
Philips
Philips
3 days ago

Senior Quality Manager-Advanced Imaging

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Last checked: 13 hours agoStatus: Live

Job Summary

Lead the Quality Management System (QMS) and Design Assurance for image guided therapy products across the full lifecycle. Ensure compliance with global regulations and standards (FDA QMSR, ISO 13485, EU MDR), manage audits/inspections as the primary quality representative, drive CAPA and nonconformance investigations, and use quality KPIs and risk management to improve product safety and performance. Partner cross-functionally with R&D, Operations, and Regulatory Affairs to execute quality strategy.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Lead Quality as a strategic member of the leadership team to build a culture of quality, compliance, and continuous improvement.
  • •Oversee QMS compliance to applicable regulations and standards, including serving as the primary quality representative for inspections, external audits, and regulatory interactions.
  • •Establish and continuously improve quality processes, systems, and procedures to deliver safe, effective, high-quality products.
  • •Oversee design assurance activities across the product lifecycle, including design controls, verification/validation, design transfer, and process validation.
  • •Lead investigations, root cause analyses, CAPA, and nonconformance corrective actions; drive audit readiness and use quality metrics to guide improvements.
Travel: Low travel

Pay and Benefits

Salary: USD 134,000 - 213,000 annually
Perks:Paid Leave401kHsaEquity

Key Requirements

  • •8+ years of experience in FDA-regulated medical device environments focused on QMS compliance and Design Assurance.
  • •Experience leading and managing quality teams, including budgeting, performance management, coaching, succession planning, and employee development.
  • •Strong knowledge of medical device regulations/standards including ISO 13485/14971 and FDA 21CFR (803, 806, 820).
  • •Experience overseeing design assurance across the product lifecycle, including design controls, verification/validation, risk management, design transfer, and process validation.
  • •Bachelor’s degree in Quality, Engineering, or a similar discipline.
  • •years_experience_minimum may exceed if included?
  • •You must be able to perform physical, cognitive, and environmental job requirements with or without accommodation.
Experience:Medical devicesFDA regulatedQuality management
Education:Bachelor's in Quality or Engineering
Skills:LeadershipCross-functional collaborationData-based decision-makingCoachingRisk management
Tech Stack:Quality Management System (QMS)Design AssuranceFDA QMSRISO 13485European Medical Device Regulation (MDR)21CFR (803, 806, 820)ISO 14971DFMEAPFMEAGMPGDPLeanSix SigmaCAPANonconformance managementProcess validationDesign controlsVerificationValidationDesign transfer

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