About this opportunity
Intellectt Inc lists this Principal Engineer | CAPA / Quality Systems opportunity in draper, Utah. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Principal Engineer | CAPA / Quality Systems
Location: Draper, UT – Onsite
Experience: 8-10 years
Contract: 12+ months with Possible extension
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 .
#J-18808-Ljbffr
Worksite address
draper, UT, 84020, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.