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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in FDA regulated medical device environments, focusing on QMS Compliance, CAPA processes, and strategic leadership of quality teams. Proven ability to drive process improvements, manage compliance with industry regulations, and mentor engineering talent.
Highest-signal resume keywords
QMS ComplianceCAPA ProcessFDA 21 CFR Part 820ISO 13485Risk Management (ISO 14971)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process ImprovementData AnalysisRoot Cause AnalysisProcess ValidationDesign Transfer Activities
Soft Skills
LeadershipMentoringCollaborationCommunicationTalent Management
Tools & Technologies
Quality Management System (QMS)PFMEACost of Poor Quality Data
Industry Keywords
FDA RegulatedMedical Device StandardsInternal AuditRegulatory InspectionsNon-Conformances (NC)
About the role
Key responsibilities & impact- Spearhead strategic development and deployment of Enterprise quality controls and process improvements
- Lead organization-wide compliance initiatives and drive integration of new tools and processes
- Analyze data for trends, risks, and improvement opportunities
- Elevate supplier quality standards with R&D, manufacturing, and regulatory affairs teams
- Guide acceptance activities, manufacturing transfer, process deficiencies, NPI validations, process development, process controls, inspection plans, and control plans
- Integrate initiatives into site QMS processes with the Quality Optimization team
- Drive cost reduction and productivity using Cost of Poor Quality data
- Manage compliance with industry regulations and documentation
- Lead talent management and succession planning
- Authorize assessment of PFMEA and associated controls related to design changes
- Assist with Manufacturing Process Development and Design Transfer activities
- Mentor quality engineers and cultivate continuous learning and knowledge sharing
- Support NPI projects and product transfers within the manufacturing facility
- Interact frequently with senior management across several functional areas
- Lead employee selection, performance management, compensation management, and career development
Requirements
What you’ll need- 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)
- Minimum of a Bachelor’s degree (Required) in Engineering, Life Sciences, or related technical field
- Ability to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation
- US work authorization required; candidates requiring sponsorship now or in the future will not be considered
- Must reside in or within commuting distance to Plymouth, MN, Latham, NY, or Cambridge, MA
Benefits
Comp & perks- Annual incentive bonus may be offered
- Sales commission may be offered
- Long-term incentives may be offered
- Generous PTO
- 401k with up to 7% match
- HSA with company contribution
- Stock purchase plan
- Education reimbursement
- Philips Total Rewards benefits program
- Up to 25% travel may be required