Philips

1 month ago

Director, Process Compliance & Centers of Excellence

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Director leading enterprise quality controls and process improvements in FDA-regulated medical device environments. Drives cross-functional compliance initiatives, integrates new tools/processes, analyzes data for trends and risks, and guides NPI validations, PFMEA, and design transfer to elevate supplier quality and site QMS performance.

Location: Netherlands

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Seniority: Sr. Director level

Key Responsibilities

•Spearhead strategic development and deployment of robust enterprise quality controls and process improvements across the organization.
•Lead acceptance activities, transfer to manufacturing, develop New Product Introduction (NPI) validations, process development, process controls, inspection plans, and control plans.
•Collaborate with Quality Optimization to integrate initiatives into site QMS processes.
•Analyze data to identify trends, risks, and improvement opportunities and proactively support process improvement.
•Drive cost reduction and productivity through COPQ data analysis and support implementation of cost-saving initiatives

Travel: Medium travel

Key Requirements

•10+ years in FDA-regulated medical device environments with extensive focus in QMS Compliance, CAPA, Internal Audit, and process/continuous improvement
•5+ years 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/regulatory inspections (FDA, Notified Bodies)

Experience:10+ yearsMedical devicesFDA regulatedQMSCAPANPIPFMEA

Education:Bachelor's

Skills:LeadershipTeam managementCommunicationProblem-solvingStrategic thinking

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, Process Compliance & Centers of Excellence

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Location: Netherlands

Workplace: Onsite

Employment Type: Full time

Job Function: Legal, Risk & Compliance

Seniority: Sr. Director level

Key Responsibilities

•Spearhead strategic development and deployment of robust enterprise quality controls and process improvements across the organization.
•Lead acceptance activities, transfer to manufacturing, develop New Product Introduction (NPI) validations, process development, process controls, inspection plans, and control plans.
•Collaborate with Quality Optimization to integrate initiatives into site QMS processes.
•Analyze data to identify trends, risks, and improvement opportunities and proactively support process improvement.
•Drive cost reduction and productivity through COPQ data analysis and support implementation of cost-saving initiatives

Travel: Medium travel

Key Requirements

•10+ years in FDA-regulated medical device environments with extensive focus in QMS Compliance, CAPA, Internal Audit, and process/continuous improvement
•5+ years 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/regulatory inspections (FDA, Notified Bodies)

Experience:10+ yearsMedical devicesFDA regulatedQMSCAPANPIPFMEA

Education:Bachelor's

Skills:LeadershipTeam managementCommunicationProblem-solvingStrategic thinking

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