Senior CAPA Quality Engineer — Medical Devices

Infosoft Inc.; Draper (UT); On-site; USD 76,000 - 80,000; Full time

Job summary

Infosoft Inc. in Draper, UT, seeks a Senior Quality Engineer (CAPA) for a 12-month assignment with a pay rate of $55–$58.27 per hour.

You will own CAPAs end-to-end, drive root-cause investigations, and ensure ISO 13485 and 21 CFR 820.100 compliance while coordinating with cross-functional teams. The role requires strong technical writing, expertise with eQMS systems, and the ability to apply statistical methods and trend analysis to verify effectiveness.

Qualifications

• Strong CAPA management experience.
• Proficient in root cause investigations (5 Whys, Fishbone, FTA, 8D/DMAIC).
• Solid regulatory compliance knowledge (FDA, ISO 13485).
• Skilled in statistical analysis and data trend evaluation.
• Able to collaborate across Manufacturing, Operations, R&D and Supplier Quality.

Responsibilities

• Own CAPAs from issue assessment to closure per ISO 13485 and 21 CFR 820.100.
• Lead structured root cause investigations and document conclusions with rationale.
• Draft investigation reports and CAPA documentation for FDA/Notified Body audits.
• Ensure eQMS documentation is complete, accurate, and traceable (GDP).
• Support updates to SOPs, forms, DHRs, and inspection methods.
• Collaborate with floor teams to implement corrective/preventive actions.
• Define and execute effectiveness checks with statistical trend analysis.

Skills

CAPA management

Root cause analysis

Regulatory compliance

Statistical analysis

Cross-functional collaboration

Quality systems

Tools

TrackWise

Agile

Veeva

Job description

Infosoft Inc. in Draper, UT, seeks a Senior Quality Engineer (CAPA) for a 12-month assignment with a pay rate of $55–$58.27 per hour.

You will own CAPAs end-to-end, drive root-cause investigations, and ensure ISO 13485 and 21 CFR 820.100 compliance while coordinating with cross-functional teams. The role requires strong technical writing, expertise with eQMS systems, and the ability to apply statistical methods and trend analysis to verify effectiveness.