Senior Quality Lead – Quality Compliance
Philips
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • Minnesota • United States
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Salary
💰 $120,488 - $205,632 per year
Job Level
About the role
- Act as Subject Matter Expert (SME) for non-conformance
- Implement and provide oversight of consistent global Quality and Regulatory requirements
- Oversee the Quality Assurance activities related to the manufacturing of materials, components, sub-assemblies, and completed products
- Serve as best practice/quality resource within your discipline or as technical expert on functional or cross-functional teams/projects
Requirements
- 7+ years’ experience in quality engineering within FDA regulated medical device manufacturing environments
- Strong knowledge of principles, theories, and concepts relevant to Quality Engineering (CQE body of knowledge)
- Detailed knowledge of appropriate global medical device regulations, requirements and standards including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971
- Lean Six Sigma Black Belt or Master Black Belt certified
- Minimum of a Bachelor’s Degree in Quality, Engineering or related field
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
Quality EngineeringQuality AssuranceLean Six SigmaFDA regulationsISO 13485ISO 1497121 CFR Parts 80321 CFR Parts 806Manufacturing processesNon-conformance management
Soft Skills
Subject Matter ExpertBest practice resourceTechnical expertiseCross-functional collaborationOversightImplementationCommunicationLeadershipOrganizational skillsProblem-solving
Certifications
Lean Six Sigma Black BeltLean Six Sigma Master Black Belt