Philips

3 months ago

Senior Quality Systems Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 18 hours agoStatus: Live

Job Summary

Quality Systems Engineer responsible for maintaining a compliant Quality Management System (QMS) in FDA-regulated medical device environments, leading audits, CAPA, document control, training, risk assessments, and continuous improvement initiatives to ensure regulatory compliance and operational excellence.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: IT Operations (Systems/Network Admin)

Key Responsibilities

•Own quality processes including audits, document control, training, and CAPA to ensure an efficient and compliant QMS.
•Analyze QMS metrics and performance indicators, prepare detailed reports, and present findings to senior management to drive improvements.
•Contribute to development and revision of QMS processes, SOPs, work instructions, and quality manuals with accuracy and regulatory alignment.
•Perform risk assessments to identify regulatory/compliance risks and develop mitigation strategies.
•Lead cross-functional problem-solving and host audits/inspections, ensuring readiness and effective responses to findings.

Travel: Low travel

Pay and Benefits

Salary: USD 102,480 - 163,968 annually

Perks:401kPaid LeaveHsaEquity

Key Requirements

•Minimum 5+ years in FDA-regulated (ISO 13485) medical device quality operations/manufacturing with focus on QMS compliance (audits, CAPA, document control, training)
•Experience managing/maintaining training metrics/matrix
•Proven ability to lead cross-functional teams and mentor engineers
•Detailed experience with CAPA processes, root cause analysis, and implementing preventive solutions
•Bachelor's Degree in Quality, Engineering, or similar; ASQ-CQE and ISO Lead Auditor certifications desired

Experience:5+ yearsMedical devicesFDA regulatedQMSISO 13485

Education:Bachelor's in Quality/Engineering

Skills:CommunicationLeadershipProblem-solvingData analysisMentoring

Certifications:ASQ-CQEISO Lead Auditor

Languages:English

Tech Stack:CAPAQMSSOPsRoot cause analysisAudits

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 months ago

Senior Quality Systems Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 18 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: IT Operations (Systems/Network Admin)

Key Responsibilities

•Own quality processes including audits, document control, training, and CAPA to ensure an efficient and compliant QMS.
•Analyze QMS metrics and performance indicators, prepare detailed reports, and present findings to senior management to drive improvements.
•Contribute to development and revision of QMS processes, SOPs, work instructions, and quality manuals with accuracy and regulatory alignment.
•Perform risk assessments to identify regulatory/compliance risks and develop mitigation strategies.
•Lead cross-functional problem-solving and host audits/inspections, ensuring readiness and effective responses to findings.

Travel: Low travel

Pay and Benefits

Salary: USD 102,480 - 163,968 annually

Perks:401kPaid LeaveHsaEquity

Key Requirements

•Minimum 5+ years in FDA-regulated (ISO 13485) medical device quality operations/manufacturing with focus on QMS compliance (audits, CAPA, document control, training)
•Experience managing/maintaining training metrics/matrix
•Proven ability to lead cross-functional teams and mentor engineers
•Detailed experience with CAPA processes, root cause analysis, and implementing preventive solutions
•Bachelor's Degree in Quality, Engineering, or similar; ASQ-CQE and ISO Lead Auditor certifications desired

Experience:5+ yearsMedical devicesFDA regulatedQMSISO 13485

Education:Bachelor's in Quality/Engineering

Skills:CommunicationLeadershipProblem-solvingData analysisMentoring

Certifications:ASQ-CQEISO Lead Auditor

Languages:English

Tech Stack:CAPAQMSSOPsRoot cause analysisAudits

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