Principal Quality Engineer

Spectraforce; Draper (UT); On-site; USD 120,000 - 170,000; Full time

Job summary

Spectraforce is seeking a Principal Quality Engineer to lead CAPA activities onsite in Utah. The role emphasizes ownership of complex CAPAs, guiding a team of CAPA professionals, and ensuring action plans are effective and well-documented.

You will support CAPA governance, prepare review materials, and interact with auditors and customers as needed to defend records and commitments. Strong QA leadership and regulatory alignment are essential.

Responsibilities

• Take ownership of designated high-complexity CAPAs and accelerate CAPA processing.
• Provide guidance and day-to-day technical direction to CAPA personnel, reviewing investigations and action plans.
• Support CAPA Chair: prepare materials, pre-screen records, and track board decisions.
• Ensure CAPA documentation integrity, traceability, and audit readiness across closed and in-flight records.
• Act as SME during FDA inspections and customer audits when needed.

Job description

Position Title: Principal Quality Engineer

Work Arrangement: Onsite

Position 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.

Key Responsibilities:

• 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.

Qualification & Experience: