Director of Quality and Compliance

Philips
San Diego
Workplace: OnsiteFull timeUSD 170,000 - 270,000 annuallyFunction: Legal, Risk & ComplianceExperience: 10+ yearsEducation: bachelorsSkills: ["Leadership","Change management","Stakeholder management","Strategic thinking","Communication"]

Lead and manage the Image Guided Therapy Devices (IGTD) quality systems team to harmonize and simplify the Quality Management System (QMS). Ensure QMS compliance with FDA and other regulatory requirements, industry standards, and internal policies, including change management, audits, CAPA, and quality KPI reporting. Serve as a strategic advisor to senior leadership and the Business Category Leadership Team, partnering cross-functionally to drive operational excellence and integrate quality objectives into business decisions.

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FursaFursa
Philips
Philips
1 month ago

Director of Quality and Compliance

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Source: Company careers pageValidated by: Fursa AI
Last checked: 27 days agoStatus: Live

Job Summary

Lead and manage the Image Guided Therapy Devices (IGTD) quality systems team to harmonize and simplify the Quality Management System (QMS). Ensure QMS compliance with FDA and other regulatory requirements, industry standards, and internal policies, including change management, audits, CAPA, and quality KPI reporting. Serve as a strategic advisor to senior leadership and the Business Category Leadership Team, partnering cross-functionally to drive operational excellence and integrate quality objectives into business decisions.
Location: San Diego
Workplace: Onsite
Employment Type: Full time
Job Function: Legal, Risk & Compliance
Seniority: Director level

Key Responsibilities

  • •Lead, manage, and develop the IGTD quality systems team while driving an inclusive and supportive environment.
  • •Ensure the effective operation and evolution of the QMS, maintaining compliance with regulatory, industry, and internal requirements, including PDLM/mfg process compliance.
  • •Advise senior leadership on quality-related matters and develop/implement strategic QMS programs aligned with business objectives.
  • •Enforce QMS harmonization across business sites/sector, establish management review processes, and implement quality processes/tools to support product quality and customer satisfaction.
  • •Act as quality representative on the Business Category Leadership Team, partnering cross-functionally to resolve quality challenges, drive operational excellence, and integrate quality objectives into business decisions.
Travel: Low travel

Pay and Benefits

Salary: USD 170,000 - 270,000 annually
Perks:Paid Leave401kHsa

Key Requirements

  • •10+ years of experience in global, FDA-regulated medical device quality environments, including strategic and functional leadership of diverse quality teams.
  • •Experience implementing and evolving Quality Management Systems (QMS), including simplification/standardization, CAPA, change management, and internal/external audits for multi-site businesses.
  • •Knowledge of global medical device regulations and standards, including FDA, ISO 13485, ISO 14971, and EUMDR.
  • •Ability to use and monitor KPIs to assess team and QMS performance and drive continuous process improvement using FDA-regulated QMS best practices.
  • •A Bachelor’s degree in Quality, Life Sciences, Engineering, or a similar technical discipline (Master’s in business/management/quality strongly preferred).
Experience:10+ yearsMedical devicesFDA regulatedGlobal qualityMulti-siteMedical device compliance
Education:Bachelor's in Quality, Life Sciences, Engineering
Skills:LeadershipChange managementStakeholder managementStrategic thinkingCommunication

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