Director, Quality Programs (PMO) – Ambulatory Monitoring & Diagnostics
philips · Linwood
Job description
About the role
The Director, Quality Programs (PMO) for Ambulatory Monitoring & Diagnostics leads the global quality vision, driving critical programs and ensuring alignment with business objectives and regulatory requirements.
Key responsibilities
- Provide strategic guidance to managers and drive quality improvement initiatives across the organization.
- Ensure regulatory submission processes for product compliance with FDA, EU‑MDR, ISO 13485 and related standards.
- Lead program planning, budgeting, staffing and execution across product manufacturing sites and central Philips entities.
- Oversee Person Responsible for Regulatory Compliance duties, technical documentation and post‑market surveillance.
Required profile
- Minimum 10+ years leading global quality programs in FDA‑regulated medical device manufacturing or supply chain.
- 5+ years of strategic cross‑functional leadership and program management experience.
- Bachelor’s degree in Engineering, Quality, Life Sciences or related field; Lean/Six Sigma and ASQ‑CQM certifications desired.
Required skills
- Quality Management System implementation (ISO 13485, QMS transitions).
- CAPA, non‑conformance, process control and audit management.
- Regulatory knowledge: 21 CFR Parts 803, 806, 820; ISO 14971; EU MDR; Canadian MD regulations.
- Data analytics and quality KPI measurement.
- Lean, Six Sigma, ASQ‑CQM methodologies.
What we offer
- Base salary range $170,000‑$270,000 (US) with eligibility for incentive bonuses.
- Comprehensive Philips Total Rewards benefits including PTO, 401k match up to 7%, HSA contributions, stock purchase plan and education reimbursement.
- Office‑based role with hybrid work model (minimum three days on site).
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Published 2 weeks ago
Expires 1 month from now
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philips
Linwood
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