Principal Quality Engineer

Job Description

Job Description

Position: Principal Quality Engineer , Req#: 19579-1: 2 Openings

Location: Draper, UT (100% Onsite)
Duration: 12+Months Contract with the possibility of extension/conversion

Job Description:

Education and Experience:  

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

Job Responsibilities:  

• 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.