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About the Role
Spearhead the strategic development and deployment of robust Enterprise quality controls and process improvements. Lead organization-wide compliance initiatives, proactively drive integration of new tools & processes, and analyze data for trends and risks.
Responsibilities
- Drive strategic initiatives to elevate supplier quality standards, collaborating with R&D, manufacturing, and regulatory affairs to address process gaps and maintain quality benchmarks.
- Guide setup of acceptance activities, including transfer to manufacturing, resolve process deficiencies, and develop NPI validations, process development, process controls, inspection plans, and control plans.
- Collaborate with the Quality Optimization team to integrate initiatives into site QMS processes.
- Analyze data to identify trends, risks, and improvement opportunities, and proactively support process improvement.
- Drive cost reduction and productivity through analysis of COPQ data and assist teams with implementation of cost-saving initiatives.
- Manage compliance with industry regulations and oversee documentation preparation and maintenance.
- Lead talent management and succession planning, developing a high-performing team aligned with organizational goals.
- Authorize the assessment of impact to PFMEA and associated controls in relation to design changes, and assist in Manufacturing Process Development and Design Transfer activities.
- Mentor and cultivate a culture of continuous learning and knowledge sharing among quality engineers, ensuring effective support for NPI projects and seamless product transfers.
- Act as an expert within the field with expert knowledge of products/services and advanced quality engineering techniques, frequently interacting with senior management on cross-functional matters.
- Work on complex issues, drawing on in-depth organizational understanding to analyze situations effectively and contribute to organizational objectives.
- Utilize broad cross-functional experience, demonstrate leadership exposure in a technical capacity, and familiarity with project management practices.
- Lead succession planning and talent management, driving employee selection, performance management, compensation management, and career development.
Requirements
- 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.
- Minimum of 5+ years’ experience in functional/strategic leadership of quality teams/organizations within global, matrixed organizations.
- Robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical device standards.
- Detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
- Extensive experience leading/supporting regulatory inspections (FDA, Notified Bodies).
- Proven experience leading strategic process validation initiatives, CAPA processes, Non-Conformances (NC) and Quality Notifications (QN).
- Must be able to successfully perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Must reside in or within commuting distance to Plymouth, MN, Latham, NY or Cambridge, MA.
Skills
- QMS Compliance
- CAPA process
- Internal Audit
- Process Improvement
- Continuous Improvement
- FDA 21 CFR Part 820
- ISO 13485
- EUMDR
- Risk Management (ISO 14971)
- PFMEA
- Root Cause Analysis
- Design Transfer
- Regulatory Inspections
- Process Validation
- Non-Conformances (NC)
- Quality Notifications (QN)
- Project Management
Location
- Plymouth, MN
- Latham, NY
- Cambridge, MA
Work Type
- Office-Based
- Travel up to 25%
Experience Level
- Director
- 10+ years experience
- 5+ years leadership experience
Education Level
- Bachelor’s degree in Engineering, Life Sciences, or related technical field
- Master’s degree preferred (MBA, MS, or equivalent)
Salary/Compensations
- $170,000 to $270,000 (Plymouth, MN)
- $162,000 to $258,000 (Latham, NY)
- $181,000 to $288,000 (Cambridge, MA)
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
About the Company
- A health technology company built on the belief that every human matters.
- Dedicated to improving lives by ensuring everyone, everywhere has access to quality healthcare.
Equal Opportunity
- Equal Employment and Opportunity Employer including Disability/Vets
- Maintains a drug-free workplace.