CAPA Quality Engineer - Root Cause & Compliance Pro

Infosoft Inc.; Draper (UT); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Infosoft Inc. in Utah is seeking a Quality Engineer (CAPA) to own CAPA records from issue assessment through containment, root cause, action plans, and effectiveness verification, in compliance with ISO 13485:2016 and 21 CFR 820.100.

You will lead investigations and document conclusions with defensible technical rationale. The role requires collaboration with Manufacturing, Operations, R&D, and Supplier Quality on the floor to implement corrective actions, perform effectiveness checks with

Qualifications

• Experience leading CAPA investigations and documenting conclusions.
• Proven ability to withstand FDA/notified body audits with strong technical writing.
• Knowledge of ISO 13485:2016 and 21 CFR 820.100.

Responsabilités

• Own assigned CAPAs from issue assessment to closure.
• Lead root cause investigations using 5 Whys, Ishikawa, and 8D/DMAIC.
• Author CAPA reports for FDA, Notified Bodies, and internal audits.
• Ensure compliant, traceable eQMS documentation with GDP adherence.
• Support SOP/work instruction updates stemming from CAPA actions.
• Collaborate with Manufacturing, Operations, R&D, and Supplier Quality on the floor.
• Define and execute effectiveness checks with statistics and trend analysis.
• Present status at the CAPA Review Board.

Connaissances

CAPA ownership

Root cause analysis

5 Whys

Fishbone/Ishikawa

8D/DMAIC

Technical writing

FDA compliance

Data trend analysis

Cross-functional collaboration

Outils

TrackWise

Agile

Veeva

eQMS

Description du poste

Infosoft Inc. in Utah is seeking a Quality Engineer (CAPA) to own CAPA records from issue assessment through containment, root cause, action plans, and effectiveness verification, in compliance with ISO 13485:2016 and 21 CFR 820.100.

You will lead investigations and document conclusions with defensible technical rationale. The role requires collaboration with Manufacturing, Operations, R&D, and Supplier Quality on the floor to implement corrective actions, perform effectiveness checks with