Philips

3 weeks ago

Supplier Quality Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Drive supplier performance and continuous quality improvement for Philips’ Image Guided Therapy Devices (IGTD) Quality team. Coordinate supplier improvement initiatives, manage Approved Supplier Lists and Supplier Quality Agreements, and lead sustaining SQE activities including NCR/SCAR/SCR reviews and APQP. Assess supplier capabilities, monitor quality and performance trends, troubleshoot production/release issues, and oversee equipment qualification and process validation while ensuring compliance with medical device regulations and standards.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Coordinate and execute supplier improvement initiatives, including managing the Approved Supplier List and negotiating Supplier Quality Agreements.
•Perform sustaining SQE activities by managing daily NCRs, SCARs, SCNs, and the ASL, and managing APQP with selected suppliers.
•Facilitate technical capability assessments for potential new suppliers and contribute to supplier selection.
•Monitor and measure product/process quality and performance trends, troubleshoot production/release issues, and assist in approved supplier list changes.
•Provide quality oversight for supplier-driven product/process change requests, conduct supplier defect analysis and supplier corrective action review, and lead equipment qualification and process validation plans.

Travel: Low travel

Pay and Benefits

Salary: USD 103,000 - 163,000 annually

Perks:Paid Leave401kHsaEquity

Key Requirements

•Minimum 5+ years of Supplier Quality Engineering experience in FDA-regulated medical device environments, including supplier selection, performance assessment, APQP, Risk Assessments/PFMEA, SPC, and SCAR/CAPA remediation activities.
•Detailed knowledge of medical device regulations and standards including 21 CFR Parts 803, 806, and 820; ISO 13485 and ISO 14971; and relevant EU and Canadian medical device regulations.
•Proven ability to use data analytics/KPIs to assess supplier performance and drive process improvement opportunities.
•Strong communication skills to effectively influence and build cross-functional relationships with internal teams, suppliers, Regulatory Agencies, and Notified Bodies.
•Bachelor’s degree in Quality, Engineering, or related disciplines; ASQ and/or Six Sigma DfX certifications desired.

Experience:5+ yearsFDA regulated medical devicesMedical devicesQuality engineering

Education:Bachelor's in Quality, Engineering, or related disciplines

Skills:CommunicationStakeholder managementData analysisProcess improvementCross-functional collaboration

Certifications:ASQSix Sigma DfX

Tech Stack:APQPRisk AssessmentsPFMEASPCSCARSICRCAPARemediationNCRISO 13485ISO 1497121 CFR Part 80321 CFR Part 80621 CFR Part 820EU 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: 3.8

Website LinkedIn

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Philips

3 weeks ago

Supplier Quality Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Coordinate and execute supplier improvement initiatives, including managing the Approved Supplier List and negotiating Supplier Quality Agreements.
•Perform sustaining SQE activities by managing daily NCRs, SCARs, SCNs, and the ASL, and managing APQP with selected suppliers.
•Facilitate technical capability assessments for potential new suppliers and contribute to supplier selection.
•Monitor and measure product/process quality and performance trends, troubleshoot production/release issues, and assist in approved supplier list changes.
•Provide quality oversight for supplier-driven product/process change requests, conduct supplier defect analysis and supplier corrective action review, and lead equipment qualification and process validation plans.

Travel: Low travel

Pay and Benefits

Salary: USD 103,000 - 163,000 annually

Perks:Paid Leave401kHsaEquity

Key Requirements

•Minimum 5+ years of Supplier Quality Engineering experience in FDA-regulated medical device environments, including supplier selection, performance assessment, APQP, Risk Assessments/PFMEA, SPC, and SCAR/CAPA remediation activities.
•Detailed knowledge of medical device regulations and standards including 21 CFR Parts 803, 806, and 820; ISO 13485 and ISO 14971; and relevant EU and Canadian medical device regulations.
•Proven ability to use data analytics/KPIs to assess supplier performance and drive process improvement opportunities.
•Strong communication skills to effectively influence and build cross-functional relationships with internal teams, suppliers, Regulatory Agencies, and Notified Bodies.
•Bachelor’s degree in Quality, Engineering, or related disciplines; ASQ and/or Six Sigma DfX certifications desired.

Experience:5+ yearsFDA regulated medical devicesMedical devicesQuality engineering

Education:Bachelor's in Quality, Engineering, or related disciplines

Skills:CommunicationStakeholder managementData analysisProcess improvementCross-functional collaboration

Certifications:ASQSix Sigma DfX

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Philips

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: 3.8

Website LinkedIn