Site Leader (Director), Operations Quality Assurance-Ultrasound

Philips
United States
Workplace: OnsiteFull timeUSD 162,000 - 258,000 annuallyFunction: QA, Test & Release EngineeringExperience: 10+ yearsEducation: bachelorsSkills: ["Strategic leadership","Collaboration","Communication","Change management","Executive presence"]

Lead Operations Quality Assurance across Philips’ Reedsville and Bothell Ultrasound manufacturing sites, ensuring medical devices, processes, and quality system activities meet regulatory and company standards. Own the Operations Quality Strategy, maintain inspection readiness as the designated Quality Management Representative, and drive audit finding resolution through root-cause analysis and CAPA. Lead manufacturing quality and quality systems, establish quality metrics, and build a high-performing Quality organization.

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Philips
Philips
1 month ago

Site Leader (Director), Operations Quality Assurance-Ultrasound

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

Job Summary

Lead Operations Quality Assurance across Philips’ Reedsville and Bothell Ultrasound manufacturing sites, ensuring medical devices, processes, and quality system activities meet regulatory and company standards. Own the Operations Quality Strategy, maintain inspection readiness as the designated Quality Management Representative, and drive audit finding resolution through root-cause analysis and CAPA. Lead manufacturing quality and quality systems, establish quality metrics, and build a high-performing Quality organization.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Director level

Key Responsibilities

  • •Lead Operations Quality Assurance activities across the Reedsville and Bothell manufacturing sites to ensure compliance, product quality, patient safety, and operational quality performance.
  • •Develop and execute the Operations Quality Strategy and translate enterprise quality objectives into measurable site priorities to drive inspection readiness and continuous improvement.
  • •Represent the organization during regulatory inspections/external audits as the designated Quality Management Representative and ensure QMS effectiveness and compliance.
  • •Ensure compliance of products, manufacturing processes, and quality system activities with FDA regulations and global requirements (including ISO 13485, ISO 14971, MDSAP, EU MDR).
  • •Drive timely resolution of audit findings and compliance gaps, including root cause analysis and sustainable corrective actions, and lead Quality Systems/Manufacturing Quality/CAPA/NCM/Validation oversight.
Travel: Low travel

Pay and Benefits

Salary: USD 162,000 - 258,000 annually
Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

  • •10+ years of progressive leadership experience in FDA-regulated medical device manufacturing environments.
  • •Demonstrated leadership across Quality Systems, Manufacturing Quality, Supplier Quality, CAPA, Nonconformance Management, Validation, and Product Release.
  • •Deep knowledge of FDA regulations and medical device quality standards including ISO 13485, ISO 14971, MDSAP, and EU MDR.
  • •Experience serving as a Quality Management Representative and leading through regulatory inspections and external audits.
  • •Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical field (advanced degree preferred).
Experience:10+ yearsMedical devicesFDA-regulated manufacturingQuality systemsCAPAISO 13485
Education:Bachelor's
Skills:Strategic leadershipCollaborationCommunicationChange managementExecutive presence
Tech Stack:FDAISO 13485ISO 14971MDSAPEU MDRQuality Management SystemCAPANonconformance ManagementValidationProduct Release

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