Senior CAPA Quality Engineer – FDA/ISO

Planet Pharma; Draper (UT); On-site; USD 110,000 - 140,000; Full time

Job summary

Planet Pharma seeks a CAPA Engineer to own end-to-end CAPA processes from issue assessment to effectiveness checks in a regulated medical device environment. You will lead structured investigations and ensure compliant documentation within the eQMS, partnering with Manufacturing, R&D, and QA teams to implement corrective actions.

The role requires a Bachelor's degree in engineering and experience with ISO 13485:2016 and FDA 21 CFR 820.100.

Qualifications

• Bachelor's degree in engineering is required.
• Experience with ISO 13485:2016 and FDA 21 CFR 820.100 preferred.
• Strong technical writing and investigation/reporting skills.

Responsibilities

• Lead CAPA investigations and closure per regulatory requirements.
• Draft high-quality CAPA investigation reports and documentation.
• Ensure eQMS entries are complete, traceable, and data-integrity compliant.
• Support updates to SOPs, work instructions, forms, DHRs, and inspection methods.
• Collaborate with Manufacturing, Operations, R&D, and Supplier Quality on corrective actions.
• Define and execute effectiveness checks using statistical methods and trend analysis.
• Present status at the CAPA Review Board.

Skills

CAPA management

Root cause analysis

5 Whys

Ishikawa

8D DMAIC

Quality systems

Statistics

Education

Bachelor's degree in engineering

Tools

TrackWise

Agile

Veeva

Job description

Planet Pharma seeks a CAPA Engineer to own end-to-end CAPA processes from issue assessment to effectiveness checks in a regulated medical device environment. You will lead structured investigations and ensure compliant documentation within the eQMS, partnering with Manufacturing, R&D, and QA teams to implement corrective actions.

The role requires a Bachelor's degree in engineering and experience with ISO 13485:2016 and FDA 21 CFR 820.100.