Principal Engineer

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

Principal Engineer (JN -092026-431558) Draper, Utah

Salary: USD57 - USD63.76 per hour

W-2 Contract

Duration - 12 Months

Location - Draper, UT 84020

Pay -$57to $63.76/hour

Summary:

Take personal ownership and processing of designated high-complexity, high-visibility CAPAs while driving overall CAPA process acceleration across the site portfolio.

Provide guidance, coaching, and day-to-day technical direction to additional CAPA personnel — including the contract Sr. Quality Engineers — balancing workload and reviewing investigations, action plans, and effectiveness checks prior to routing.

Support the CAPA Chair: prepare CAPA Review Board materials, pre-screen records for board readiness, present portfolio status and aging, and follow through on board decisions and commitments.

Support Quality System updates and modifications, leading or approving revisions to CAPA procedures, templates, and training content, and performing gap analysis against ISO 13485, 21 CFR 820/QMSR, and MDSAP expectations.

Ensure documentation compliance across the CAPA subsystem — record integrity, traceability, and audit readiness of all closed and in-flight records.

Apply risk-based decision-making to determine the impact of systemic nonconformities on the QMS, product, and process, and to set the appropriate scope and depth of corrective action.

Connect CAPA outcomes to the broader quality system — complaints, NCs, internal/external audit findings, risk management, and Management Review — to identify and close systemic gaps.

Preferred: Act as SME during FDA inspections, Notified Body, and customer audits: defend CAPA records, draft and negotiate audit responses, and manage follow-up commitments to closure.

Education/Experience:

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