Senior CAPA Engineer
Philips
full-time
Posted on:
Location Type: Hybrid
Location: Orlando • Florida • Massachusetts • United States
Visit company websiteExplore more
Salary
💰 $87,000 - $139,200 per year
Job Level
About the role
- advise and critically review Corrective and Preventive Actions (CAPAs)
- facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring
- perform timely, detailed CAPA engineering tasks
- project manage all aspects of CAPA activity
- represent CAPAs during audits and CAPA Review Board meetings
- lead and mentor cross-functional teams with root cause analysis techniques
- analyze quality monitoring data and apply statistical techniques to identify non-conformances
- perform periodic trend analysis and corrective action effectiveness measures
Requirements
- 5+ years’ experience in Quality Engineering within FDA regulated medical device environments
- proven expertise in Corrective and Preventive Actions (CAPAs)
- experience in non-conformance, root cause analysis, and data/trend analysis
- detailed knowledge of global medical device regulations including 21 CFR Parts 803, 806, and 820
- Minimum of a Bachelor’s Degree (Required) in Quality, Engineering or related fields
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
Corrective and Preventive Actions (CAPAs)root cause analysisdata analysistrend analysisstatistical techniquesquality monitoringCAPA engineeringproject managementnon-conformanceeffectiveness monitoring
Soft skills
leadershipmentoringcommunicationcritical thinkingproblem-solvingcollaborationorganizational skillsanalytical skillsfacilitationteamwork