Principal Engineer | CAPA / Quality Systems

Principal Engineer | CAPA / Quality Systems

Experience: 8–10 years

Contract: 12+ months with Possible extension

Education: Bachelor’s degree in Engineering required

Role Summary

• Own and lead high-complexity, high-visibility CAPAs from investigation through effectiveness checks and closure.
• Provide technical guidance and coaching to CAPA engineers and review investigations, action plans, and effectiveness checks.
• Support the CAPA Review Board with readiness reviews, portfolio status, aging, presentations, and follow-up actions.
• Lead/approve CAPA procedure, template, and training updates aligned with ISO 13485, 21 CFR 820/QMSR, and MDSAP.
• Apply risk-based decision-making and connect CAPA with NCRs, complaints, audits, risk management, and Management Review.
• Act as a CAPA SME during FDA, Notified Body, and customer audits when needed.

Ideal Candidate

Look for candidates with:

• 8–10+ years in Quality Engineering / Quality Systems within medical device or regulated manufacturing.
• Strong hands-on CAPA ownership, investigation, RCA, corrective/preventive actions, and effectiveness checks.
• Experience with ISO 13485, 21 CFR 820/QMSR, MDSAP, audits, and inspection readiness.
• Experience mentoring/reviewing work of other Quality Engineers.
• Strong understanding of NCR/NC, complaints, audits, risk management, and QMS integration.