Senior CAPA & Quality Systems Engineer - Medical Devices

Intellectt Inc; Draper (UT); On-site; USD 140,000 - 190,000; Full time

Job summary

Intellectt Inc is seeking a Principal Engineer for CAPA and Quality Systems in Draper, UT, onsite. The role requires 8–10 years in medical device quality engineering and focuses on CAPA ownership, investigations, and audits.

You will mentor CAPA engineers, lead CAPA procedures, and coordinate with the CAPA Review Board, ensuring alignment with ISO 13485, 21 CFR 820/QMSR, and MDSAP during inspections and regulatory reviews.

Qualifications

• 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.

Responsibilities

• 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.

Skills

CAPA ownership

Investigation

RCA

Effectiveness checks

ISO 13485

21 CFR 820/QMSR

MDSAP

NCR/NC

Audits

Risk management

QMS integration

MentoringQuality Engineers

Job description

Intellectt Inc is seeking a Principal Engineer for CAPA and Quality Systems in Draper, UT, onsite. The role requires 8–10 years in medical device quality engineering and focuses on CAPA ownership, investigations, and audits.

You will mentor CAPA engineers, lead CAPA procedures, and coordinate with the CAPA Review Board, ensuring alignment with ISO 13485, 21 CFR 820/QMSR, and MDSAP during inspections and regulatory reviews.