Senior CAPA Quality Engineer

We are hiring Senior CAPA Quality Engineer.

Please let me know if you are interested or anyone who might be interested.

Client: Major Medical Device Client

Position: Senior CAPA Quality Engineer

Duration: 12 months on W2

Location: Draper, Utah 84020

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

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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.

Regards,

Vishnu Das Natesan

dvishnu@radiants.com