Senior CAPA & Quality Systems Engineer

Planet Pharma; Draper (UT); On-site; USD 72,000 - 1,325,000; Full time

Job summary

Planet Pharma seeks an experienced CAPA leader to own high-complexity CAPAs, drive portfolio acceleration, and provide day-to-day technical direction to CAPA personnel, including contract Sr. Quality Engineers.

You will review investigations, action plans, and effectiveness checks, while balancing workload and audit readiness. Support the CAPA Chair by preparing board materials, pre-screening records, and presenting portfolio status.

Qualifications

• Bachelor’s degree in engineering required.
• 8-10 years experience required.
• Experience with CAPA processes and QMS is preferred.

Responsibilities

• Own high‑complexity CAPAs and drive portfolio acceleration.
• Provide day‑to‑day technical direction to CAPA personnel, including contract Sr. Quality Engineers.
• Review investigations, action plans, and effectiveness checks; balance workload and ensure audit readiness.
• Support the CAPA Chair with board materials, record pre-screening, and portfolio status updates.
• Align CAPA activities with the broader quality system (complaints, NCRs, audits, risk management, mgmt review); act as SME during FDA inspections and Notified Body audits.

Skills

CAPA leadership

Quality Systems

FDA inspections

Notified Body

Education

Bachelor's degree in engineering

Job description

Planet Pharma seeks an experienced CAPA leader to own high-complexity CAPAs, drive portfolio acceleration, and provide day-to-day technical direction to CAPA personnel, including contract Sr. Quality Engineers.

You will review investigations, action plans, and effectiveness checks, while balancing workload and audit readiness. Support the CAPA Chair by preparing board materials, pre-screening records, and presenting portfolio status.