Senior CAPA Quality Engineer

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

We are hiring Senior CAPA Quality Engineer.

Client: Major Medical Device Client

Position: Senior CAPA Quality Engineer

Duration: 12+ months on W2

Pay Rate: $55.00-$68.00/ Hr on W2

Job Description

Position Summary

The Senior CAPA Quality Engineer will take personal ownership of designated high-complexity, high-visibility CAPAs while driving overall CAPA process acceleration across the site portfolio.

This role will provide guidance, coaching, and day-to-day technical direction to additional CAPA personnel, including contract Senior Quality Engineers. The position will balance workloads and review investigations, action plans, and effectiveness checks prior to routing.

Key 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 leading or approving revisions to CAPA procedures, templates, and training materials.


• Perform gap assessments against ISO 13485, 21 CFR 820/QMSR, and MDSAP requirements.


• Ensure documentation compliance across the CAPA subsystem, including record integrity, traceability, and audit readiness for closed and in-flight records.


• Apply risk-based decision-making to determine the impact of systemic nonconformities on the QMS, products, and processes.


• Determine the appropriate scope and depth of corrective and preventive actions based on identified risks.


• Connect CAPA outcomes to the broader quality system, including complaints, nonconformances, internal and external audit findings, risk management, and Management Review.


• Identify systemic quality gaps and drive appropriate actions to address and close those gaps.

Audit & Regulatory Support

• Serve as a subject matter expert during FDA inspections, Notified Body audits, and customer audits.


• Defend CAPA records and provide appropriate supporting documentation during audits and inspections.


• Draft and negotiate audit responses as needed.


• Manage audit-related follow-up commitments through successful closure.


• Ensure CAPA activities and documentation remain compliant with applicable regulatory and quality-system requirements.

Required Qualifications

• Bachelor's degree in Engineering is required.


• 8+ years of relevant experience in quality engineering, CAPA, or a related medical device/regulated industry 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.


• Experience working with cross-functional teams and multiple stakeholders.


• Strong written and verbal communication skills.


• Ability to provide technical direction, coaching, and support to other quality personnel.


• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.