Senior Quality Lead – Quality Compliance
Philips
full-time
Posted on:
Location Type: Hybrid
Location: Plymouth • Massachusetts, Minnesota, New York, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $120,488 - $192,780 per year
Job Level
Senior
About the role
- Act as Subject Matter Expert (SME) for non-conformance
- Drive non-conformance reduction and process validation maturity
- Implement and provide oversight of global Quality and Regulatory requirements
- Oversee the Quality Assurance activities in manufacturing processes
- Have an impact on introduction/validation of new/changed manufacturing processes
- Serve as best practice/quality resource within your discipline
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
- strong knowledge of Risk Management (ISO 14971, FMEA)
- Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities
- Minimum of a Bachelor’s Degree in Quality, Engineering or related field
- Lean Six Sigma Black Belt or Master Black Belt certified
Benefits
- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality EngineeringProcess ValidationNon-Conformance ReductionRisk ManagementFMEAProduction ControlsProcess ControlsGlobal Quality RequirementsRegulatory RequirementsManufacturing Processes
Soft skills
Subject Matter ExpertOversightBest PracticesQuality Resource
Certifications
Lean Six Sigma Black BeltLean Six Sigma Master Black Belt