Lead CAPA & Quality Systems Engineer (Medical Devices)

L&T Technology Services; Draper (UT); Vor Ort; USD 130.000 - 170.000; Vollzeit

Zusammenfassung

L&T Technology Services is seeking a Principal Engineer to own high-complexity CAPAs from investigation through closure, providing expert guidance across the CAPA lifecycle.

Ideal candidates have 8–10 years in Quality Engineering for medical devices or regulated manufacturing, with strong RCA, risk management, and experience mentoring other engineers; involvement in audits and QMS integration.

Qualifikationen

• 8–10+ years in Quality Engineering / Quality Systems within medical device or regulated manufacturing.
• Strong 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.

Aufgaben

• 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.

Kenntnisse

CAPA ownership

RCA

Quality Systems

Mentoring

Risk management

Audits

Jobbeschreibung

L&T Technology Services is seeking a Principal Engineer to own high-complexity CAPAs from investigation through closure, providing expert guidance across the CAPA lifecycle.

Ideal candidates have 8–10 years in Quality Engineering for medical devices or regulated manufacturing, with strong RCA, risk management, and experience mentoring other engineers; involvement in audits and QMS integration.