CAPA Quality Engineer – Medical Devices

Infosoft Inc.; Draper (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

Infosoft Inc. is seeking a Quality Engineer specializing in CAPA to lead investigations and drive corrective actions in a regulated environment.

You will own CAPAs end-to-end, from issue assessment through containment, root cause, action plans, and verification, ensuring ISO 13485 and FDA/GDP requirements are met. Responsibilities include leading cross-functional teams on floor corrections, maintaining compliant documentation, and applying statistical methods for effectiveness checks.

Qualifications

• Lead CAPA investigations and issue resolution per ISO 13485:2016 and 21 CFR 820.100.
• Document conclusions with defensible technical rationale for FDA/notified body audits.
• Ensure complete, traceable CAPA records in the eQMS with GDP adherence.
• Coordinate with Manufacturing, Operations, R&D and Supplier Quality on corrective actions.
• Apply statistical techniques and trend analysis to verify effectiveness of CAPAs.

Responsibilities

• Own assigned CAPAs from assessment to containment, root cause, action plan, and closure.
• Drive on-time completion of records and reduce cycle time and aging.
• Prepare audit-ready CAPA documentation and investigation reports.
• Support updates to SOPs, work instructions, and inspection methods post-CAPA.
• Contribute to CAPA Review Board presentations with status updates.

Skills

CAPA management

Root cause analysis

Data analysis

Technical writing

Cross-functional teamwork

Regulatory knowledge

Tools

eQMS TrackWise

eQMS Agile

eQMS Veeva

Job description

Infosoft Inc. is seeking a Quality Engineer specializing in CAPA to lead investigations and drive corrective actions in a regulated environment.

You will own CAPAs end-to-end, from issue assessment through containment, root cause, action plans, and verification, ensuring ISO 13485 and FDA/GDP requirements are met. Responsibilities include leading cross-functional teams on floor corrections, maintaining compliant documentation, and applying statistical methods for effectiveness checks.