CAPA Strategy Lead, Quality Systems & Compliance

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

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.