Philips

1 month ago

Director, Quality Management Systems & Compliance

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 12 hours agoStatus: Live

Job Summary

Strategic leader responsible for shaping and governing Philips’ Quality Management System and compliance across FDA-regulated medical device operations. Drives audit readiness, risk-based improvements, regulatory interactions, and cross-functional QMS enhancements to support operational efficiency and regulatory compliance.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Seniority: Director level

Key Responsibilities

•Provide strategic leadership to quality initiatives, aligning QMS with business objectives to support efficiency, risk management and growth.
•Advise executive leadership on regulatory changes, compliance risks, and quality trends to inform strategic decisions.
•Develop, harmonize and deploy standardized QMS frameworks aligned with regulatory requirements and business needs.
•Identify and lead projects to improve quality compliance across sites and operational areas.
•Oversee internal and external audit planning/execution and manage NB relationships to ensure audit readiness.

Travel: Medium travel

Pay and Benefits

Salary: USD 170,000 - 270,000 annually

Perks:401kEquityPaid Leave

Key Requirements

•Minimum of 10+ years’ experience in FDA-regulated medical device environments with extensive focus in QMS Compliance, as document control, internal audits, CAPA, and training programs.
•Minimum of 5+ years’ experience in functional/strategic leadership of quality teams within global, matrixed organizations.
•Robust understanding of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical device standards.
•Detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
•Extensive experience leading/supporting regulatory inspections (FDA, Notified Bodies) including Front Room expertise.

Experience:Medical devicesHealthcareFDA regulated

Education:Bachelor's

Skills:LeadershipStrategic thinkingStakeholder collaborationRegulatory awarenessRisk management

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

1 month ago

Director, Quality Management Systems & Compliance

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 12 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Seniority: Director level

Key Responsibilities

•Provide strategic leadership to quality initiatives, aligning QMS with business objectives to support efficiency, risk management and growth.
•Advise executive leadership on regulatory changes, compliance risks, and quality trends to inform strategic decisions.
•Develop, harmonize and deploy standardized QMS frameworks aligned with regulatory requirements and business needs.
•Identify and lead projects to improve quality compliance across sites and operational areas.
•Oversee internal and external audit planning/execution and manage NB relationships to ensure audit readiness.

Travel: Medium travel

Pay and Benefits

Salary: USD 170,000 - 270,000 annually

Perks:401kEquityPaid Leave

Key Requirements

•Minimum of 10+ years’ experience in FDA-regulated medical device environments with extensive focus in QMS Compliance, as document control, internal audits, CAPA, and training programs.
•Minimum of 5+ years’ experience in functional/strategic leadership of quality teams within global, matrixed organizations.
•Robust understanding of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical device standards.
•Detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
•Extensive experience leading/supporting regulatory inspections (FDA, Notified Bodies) including Front Room expertise.

Experience:Medical devicesHealthcareFDA regulated

Education:Bachelor's

Skills:LeadershipStrategic thinkingStakeholder collaborationRegulatory awarenessRisk management

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