Director, Process Compliance & Centers of 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

Job Title

Director, Process Compliance & Centers of Excellence

Job Description

The Director, Process Compliance & Centers of Excellence is responsible for spearheading the strategic development and deployment of robust Enterprise quality controls and process improvements. They will lead organization-wide compliance initiatives, proactively drive integration of new tools & processes, and analyze data for trends and risks.

Your role:

• Drives strategic initiatives to elevate supplier quality standards, collaborating closely with cross-functional teams in Research & Development (R&D), manufacturing, and regulatory affairs to address process gaps and maintain superior quality benchmarks.
• Guides setup of acceptance activities, including transfer to manufacturing resolve process deficiencies and develop New Product Introduction (NPI) validations, process development, process controls, inspection plans, and control plans.
• Collaborates with Quality Optimization team to integrate initiatives into site QMS processes.
• Analyzes data to identify trends, risks, and improvement opportunities and proactively support process improvement.
• Drive cost reduction and productivity through analysis of Cost of Poor Quality (COPQ) data and assist teams with implementation of cost saving initiatives
• Manages compliance with industry regulations and oversees the preparation and maintenance of documentation.
• Leads talent management, and succession planning and develops a high-performing team aligned with organizational goals.
• Authorizes the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
• Mentors and cultivate a culture of continuous learning and knowledge sharing among quality engineers, ensuring effective support for New Product Introduction (NPI) projects and seamless product transfers within the manufacturing facility.
• Possesses expert knowledge of products/services and advanced quality engineering techniques, recognized as expert within the field, and frequently interacts with senior management on matters around several functional areas.
• Works on complex issues, drawing on an in-depth understanding of the organization to analyze situations effectively, actively contributing to the development of organizational objectives and principles.
• Possesses broad cross-functional experience, demonstrates leadership exposure in a technical capacity, and is familiar with project management practices.
• Leads succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development in alignment with organizational operational goals.

You’re the right fit if:

• You have a minimum of 10+ years’ experience in FDA regulated medical device environments, with extensive focus in QMS Compliance, CAPA process, Internal Audit, and process/continuous improvement.
• You have a minimum of 5+ years’ experience in functional/strategic leadership of quality teams/organizations within global, matrixed organizations.
• You have robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical device standards.
• You have detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
• You have extensive experience leading/supporting regulatory inspections (FDA, Notified Bodies)
• You have proven experience leading strategic process validation initiatives, CAPA processes, Non-Conformances (NC) and Quality Notifications (QN).
• You have a minimum of a Bachelor’s degree (Required) in Engineering, Life Sciences, or related technical field - Master’s degree preferred (MBA, MS, or equivalent)
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than a part. For our Office-based teams , this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an _ Office-Based _ role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won’t stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

• The pay range for this position in Plymouth, MN is $170,000 to $270,000.
• The pay range for this position in Latham, NY is $162,000 to $258,000.
• The pay range for this position in Cambridge, MA is $181,000 to $288,000.

At Philips, _ it is not typical for an individual to be hired at or near the top end of the range _ for their role and compensation decisions are dependent upon the facts and circumstances of each case.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

Additional Information:

• US work authorization is a precondition of employment. _ The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. _
• Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN, Latham, NY or Cambridge,MA.
• This role may require travel up to 25 %

_ #LI-PH1 _

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.