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.
