CAPA Facilitator, Engineer
$97,600–$152,700 year
On-siteNewark, Delaware, United States
Job Summary
Lead CAPA system leadership by serving as a subject matter expert for root cause analysis, effectiveness checks, and sustainable corrective actions. Coordinate CAPA Review Board meetings, monitor system health for daily escalations, and own the divisional CAPA toolbox including training materials and templates. Analyze quality data to identify improvement opportunities, develop metrics dashboards, and support remediation projects across medical device and pharmaceutical functions. Partner with cross-functional teams to ensure compliance with FDA regulations, QMSR, and ISO 13485 standards while mentoring junior staff in quality fundamentals.
Required Qualifications
- Bachelor's degree or higher
- 3–8 years of experience in the medical device, IVD, or pharmaceutical industry
- increasing responsibility in quality assurance and CAPA systems
- Strong working knowledge of QMSR, ISO 13485, and global quality regulations
- Demonstrated ability to lead cross-functional teams and manage multiple workstreams
- Excellent technical writing, analytical, and problem-solving skills
- Strong interpersonal and communication skills
- Ability to present materials to director-level leadership
- Understanding of statistics and statistical analysis
Desired Qualifications
- Technical Bachelor's degree or higher preferred
- Experience with Agile or an equivalent Product Lifecycle Management system
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