What are the responsibilities and job description for the Principal Engineer | CAPA / Quality Systems position at L&T Technology Services?
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.
Salary : $60 - $65