Senior CAPA Quality Engineer - Lead Investigations

Radiant Systems Inc; Draper (UT); On-site; USD 114,000 - 141,000; Full time

Job summary

Radiant Systems Inc. in Utah seeks a Senior CAPA Quality Engineer to own high‑complexity CAPAs, drive acceleration of the CAPA program, and mentor contract Senior Quality Engineers across the site portfolio.

You will lead investigations, action plans, and effectiveness checks, prepare CAPA materials for Review Boards, and ensure alignment with ISO 13485, 21 CFR 820/QMSR, and MDSAP during audits and regulatory inspections.

Qualifications

• Bachelor's degree in Engineering is required.
• 8+ years of relevant experience in quality engineering, CAPA, or a related medical device environment.
• Strong understanding of CAPA processes and quality management systems.
• Working knowledge of ISO 13485, 21 CFR 820/QMSR, and MDSAP requirements.
• Experience managing complex CAPAs and conducting risk-based investigations.

Responsibilities

• Own and manage designated high-complexity, high-visibility CAPAs from initiation through closure.
• Drive CAPA process acceleration across the site portfolio while maintaining quality and compliance.
• Provide technical guidance, coaching, and day-to-day direction to CAPA personnel, including contract Senior Quality Engineers.
• Balance workload across CAPA resources and review investigations, action plans, and effectiveness checks prior to routing.
• Prepare CAPA Review Board materials and pre-screen CAPA records for board readiness.
• Present CAPA portfolio status, aging, and key issues to the CAPA Review Board.
• Follow through on CAPA Review Board decisions, action items, and commitments through completion.
• Support Quality System updates and modifications, including revisions to CAPA procedures and training materials.
• Perform gap assessments against ISO 13485, 21 CFR 820/QMSR, and MDSAP requirements.
• Identify systemic quality gaps and drive actions to close them.

Skills

CAPA processes

Quality management systems

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Job description

Radiant Systems Inc. in Utah seeks a Senior CAPA Quality Engineer to own high‑complexity CAPAs, drive acceleration of the CAPA program, and mentor contract Senior Quality Engineers across the site portfolio.

You will lead investigations, action plans, and effectiveness checks, prepare CAPA materials for Review Boards, and ensure alignment with ISO 13485, 21 CFR 820/QMSR, and MDSAP during audits and regulatory inspections.