Director, Process Compliance & Centers of Excellence

Philips; Plymouth (MN); Hybrid; USD 170,000 - 270,000; Full time

Job summary

Philips in Plymouth, MN seeks a Director, Process Compliance & Centers of Excellence to lead enterprise quality controls and process improvements across sites.

You will guide regulatory compliance, PFMEA, NPI validations, design transfer, cost reduction, COPQ analyses, and mentor a high-performing quality team. This office-based role requires 10+ years in FDA-regulated medical devices and leadership in global matrixed organizations.

Qualifications

• You have 10+ years' experience in FDA regulated medical device environments, with extensive focus in QMS Compliance, CAPA, Internal Audit, and process/continuous improvement.
• You have 5+ years' experience in leadership of quality teams within global, matrixed organizations.
• You have knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical device standards.
• You have knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
• You have experience leading regulatory inspections (FDA, Notified Bodies).

Responsibilities

• Lead strategic development and deployment of enterprise quality controls and process improvements.
• Drive supplier quality improvements in collaboration with cross-functional teams (R&D, manufacturing, regulatory).
• Oversee PFMEA assessment, design transfer activities and manufacturing process development.
• Mentor quality engineers and support NPI projects and product transfers.
• Drive COPQ data analysis for cost reduction and productivity improvements.

Job description

Director, Process Compliance & Centers of Excellence page is loaded## Director, Process Compliance & Centers of Excellencelocations: Plymouth, Minnesota, United States: Cambridge (US), Massachusetts, United States: Latham, New York, United Statestime type: Full timeposted on: Posted Todayjob requisition id: 592384### Job TitleDirector, Process Compliance & Centers of Excellence### Job DescriptionThe 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 .**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 .* Discover* Learn more about* Learn more about**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 .**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 orwithin 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.*At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people's health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness