Director, Process Excellence & Quality Compliance

Philips International; Plymouth (MA); On-site; USD 181,000 - 288,000; Full time

Benefits offered by this job

Generous PTO

401k with match

HSA contribution

Stock purchase plan

Education reimbursement and more

Job summary

Philips seeks a Director of Process Compliance & Centers of Excellence to lead enterprise quality controls, drive process improvements, and ensure regulatory alignment across R&D, manufacturing, and regulatory affairs.

You will develop PFMEA, design transfer activities, and mentor a high-performing team while partnering with Quality Optimization to integrate initiatives into site QMS.

Qualifications

• 10+ years of FDA regulated medical device experience with focus on QMS compliance, CAPA, Internal Audit and process improvement.
• 5+ years of strategic/functional leadership of quality teams in global matrixed organizations.
• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other medical device standards.
• Strong grounding in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer.
• Experience leading regulatory inspections (FDA, Notified Bodies) and CAPA/NC/QN programs.
• Bachelor’s degree required; Master’s degree preferred.

Responsibilities

• Spearhead strategic development and deployment of enterprise quality controls and process improvements.
• Lead organization-wide compliance initiatives and integrate new tools/processes into routines.
• Guide PFMEA assessment and design transfer activities with manufacturing and R& D.
• Mentor quality engineers and support NPI projects and product transfers.
• Drive cost reduction and productivity through COPQ data analysis and improvement initiatives.
• Oversee documentation for regulatory compliance and inspections.

Skills

FDA regulatory knowledge

QMS compliance

CAPA process

Internal Audit

Process improvement

Leadership

Regulatory inspections

PFMEA

Design transfer

Cost reduction (COPQ)

Education

Bachelor's degree in Engineering/Life Sciences

Master’s degree (MBA/MS) preferred

Job description

Philips seeks a Director of Process Compliance & Centers of Excellence to lead enterprise quality controls, drive process improvements, and ensure regulatory alignment across R&D, manufacturing, and regulatory affairs.

You will develop PFMEA, design transfer activities, and mentor a high-performing team while partnering with Quality Optimization to integrate initiatives into site QMS.