Director, Process Compliance & Centers of Excellence

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.

Youre 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 Bachelors degree (Required) in Engineering Life Sciences or related technical field - Masters 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 companys facilities. Field roles are most effectively done outside of the companys 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 wont 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 $170000 to $270000.
• The pay range for this position in Latham NY is $162000 to $258000.
• The pay range for this position in Cambridge MA is $181000 to $288000.

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 CambridgeMA.
• 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.