Principal Quality Engineer (CAPA)

Job Title: Principal Quality Engineer (CAPA)

Pay Rate: $60 to $70.78/Hr

Duration: 12 Months

Location: Draper, UT

Our Client is a Global medical device Manufacturer.

We are looking for a Principal Quality Engineer (CAPA)

• 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, Life Sciences, Quality, or a related technical discipline, with 8 to 10 years of experience in medical device quality, CAPA, and Quality Systems.
• Strong experience leading complex CAPAs, applying risk-based investigation and root-cause methodologies, and working with ISO 13485, 21 CFR 820/QMSR, and MDSAP requirements.
• Demonstrated technical leadership, including coaching Quality Engineers, CAPA governance, audit/inspection support, and cross-functional QMS improvement.