Senior CAPA Engineer: Quality Systems & FDA Readiness

Ultimate Staffing Services; Draper (UT); On-site; USD 79,000 - 88,000; Full time

Job summary

Ultimate Staffing Services is seeking a Principal Engineer in Draper, Utah. The role focuses on taking ownership of high-complexity CAPAs and accelerating CAPA processes across site portfolios.

You will coach CAPA personnel, review investigations and action plans, and support CAPA chair materials, ensuring documentation alignment with ISO 13485 and 21 CFR 820/QMSR standards. You may serve as SME during FDA inspections and customer audits.

Qualifications

• Bachelor's degree in engineering required.
• 8–10 years experience required.

Responsibilities

• Take ownership and processing of designated high-complexity CAPAs while driving CAPA process acceleration.
• Provide guidance, coaching, and day-to-day technical direction to CAPA personnel, balancing workload and reviewing investigations and action plans.

Skills

CAPA management

Quality assurance

Risk assessment

FDA inspections

Education

Bachelor's degree in engineering

Tools

ISO 13485

21 CFR 820

Job description

Ultimate Staffing Services is seeking a Principal Engineer in Draper, Utah. The role focuses on taking ownership of high-complexity CAPAs and accelerating CAPA processes across site portfolios.

You will coach CAPA personnel, review investigations and action plans, and support CAPA chair materials, ensuring documentation alignment with ISO 13485 and 21 CFR 820/QMSR standards. You may serve as SME during FDA inspections and customer audits.