Principal Engineer | CAPA / Quality Systems

Experience: 8–10 years

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.