Supplier Quality Engineer

Philips
United States
Workplace: OnsiteFull timeUSD 63,000 - 100,000 annuallyFunction: QA, Test & Release EngineeringExperience: 1+ yearsEducation: bachelorsSkills: ["Communication","Collaboration"]

Support supplier qualification and onboarding in the Image Guided Therapies - Devices business by executing APQP/PPAP activities, including MSA, PFMEA, control plans, SPC, PV&V, and FAI. Conduct supplier audits, qualify new suppliers for the Approved Supplier List, and investigate/disposition non-conformances. Initiate and monitor SCARs through root cause, corrective/preventive action, verification, and closure, while guiding supplier improvement efforts using quality-system and regulatory requirements.

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FursaFursa
Philips
Philips
1 month ago

Supplier Quality Engineer

âś“ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 28 days agoStatus: Live
Reposted: similar role first listed 2 months ago

Job Summary

Support supplier qualification and onboarding in the Image Guided Therapies - Devices business by executing APQP/PPAP activities, including MSA, PFMEA, control plans, SPC, PV&V, and FAI. Conduct supplier audits, qualify new suppliers for the Approved Supplier List, and investigate/disposition non-conformances. Initiate and monitor SCARs through root cause, corrective/preventive action, verification, and closure, while guiding supplier improvement efforts using quality-system and regulatory requirements.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Entry level

Key Responsibilities

  • •Execute MSA, PFMEA, control plan, SPC, PV&V, and FAI as part of APQP/PPAP activities and SICR.
  • •Support PPAP/APQP deliverables and process validation activities at the supplier, including IQ/OQ/PQ.
  • •Conduct initial qualification and for-cause supplier audits to assess compliance with quality system requirements, regulatory expectations, and supplier obligations.
  • •Qualify new suppliers for the Approved Supplier List by assessing capability, quality system maturity, technical readiness, risk classification, and onboarding documentation completion.
  • •Investigate supplier-related non-conformances and manage SCARs through root-cause analysis, corrective/preventive action, effectiveness verification, and timely closure.
Travel: Low travel

Pay and Benefits

Salary: USD 63,000 - 100,000 annually
Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

  • •Minimum 1+ years’ experience in Supplier Quality/Quality Engineering in highly regulated product environments, preferably medical device.
  • •Knowledge of medical device regulations, QMS requirements, and standards including 21 CFR Parts 803, 806, and 820.
  • •Experience with APQP/PPAP and risk assessments such as PFMEA, along with SPC and CAPA/remediation activities.
  • •Proven ability to use data analytics/KPIs to assess supplier performance and drive process improvements.
  • •Bachelor’s degree in Quality, Engineering, or a related discipline; ASQ and/or Six Sigma DfX certifications are desired.
Experience:1+ yearsMedical deviceHighly regulated environments
Education:Bachelor's in Quality, Engineering, or related disciplines
Skills:CommunicationCollaboration
Certifications:ASQSix Sigma DfX
Tech Stack:MSAPFMEAControl PlanSPCPV&VFAIAPQPPPAPSICRSCARCAPA21 CFR Part 80321 CFR Part 80621 CFR Part 820ISO 13485ISO 14971EU Medical Device RegulationEuropean Medical Device Directive (93/42/EEC)Canadian Medical Devices Regulation (SOR/98-282)

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