Director, Process Compliance & Quality Excellence

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

Benefits offered by this job

Paid time off

401k match

HSA contributions

Stock purchase plan

Education reimbursement

Job summary

Philips in Cambridge, MA seeks a Director of Process Compliance & Centers of Excellence to drive enterprise quality controls and process improvements. You will lead cross-functional programs, align PFMEA and design transfer activities, and mentor a high-performing quality team across global sites.

Role requires deep regulatory knowledge (FDA/EU MDR), strong leadership, and focus on continuous improvement and supplier quality. Office-based with potential travel and Total Rewards benefits.

Qualifications

• Minimum 10+ years in FDA-regulated medical device environments with focus on QMS compliance, CAPA, internal audits.
• Minimum 5+ years in functional/strategic leadership of quality teams within global matrixed organizations.
• Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR and other global standards.
• Experience leading/regulatory inspections (FDA, Notified Bodies).
• Ability to lead strategic process validation initiatives and risk management activities.

Responsibilities

• Spearhead strategic initiatives to elevate supplier quality and coordinate across R&D, manufacturing, and regulatory affairs.
• Lead development of NPI validations, process development, control plans, and PFMEA impact assessments.
• Integrate quality initiatives into site QMS processes and drive COPQ reduction.
• Mentor quality engineers and support NPI projects and product transfers.
• Promote a culture of continuous learning and knowledge sharing within the team.

Skills

FDA leadership

QMS expertise

CAPA & PFMEA

Regulatory inspections

Cross-functional leadership

Data trend analysis

Process improvement

Talent management

Education

Bachelor’s degree in Engineering/Life Sciences

Master’s preferred (MBA/MS)

Tools

Regulatory/documentation tools

Quality data analytics

Job description

Philips in Cambridge, MA seeks a Director of Process Compliance & Centers of Excellence to drive enterprise quality controls and process improvements. You will lead cross-functional programs, align PFMEA and design transfer activities, and mentor a high-performing quality team across global sites.

Role requires deep regulatory knowledge (FDA/EU MDR), strong leadership, and focus on continuous improvement and supplier quality. Office-based with potential travel and Total Rewards benefits.