Senior CAPA Engineer – Medical Devices

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

Job summary

Intellectt Inc in Draper, UT is seeking a CAPA specialist to own the end-to-end CAPA lifecycle, from issue assessment to effectiveness check, ensuring ISO 13485:2016 and 21 CFR 820.100 compliance. You will drive records to due dates, perform structured root cause analyses, and author investigation reports that withstand audits.

Preference for eQMS experience and implantable device background. Bachelor's degree in engineering required; collaborate with manufacturing, operations, R&D, and supplier

Qualifications

• Bachelor's degree in engineering is required.
• Experience with CAPA processes and root-cause investigations is essential.
• Strong documentation and technical writing skills to withstand audits.

Responsibilities

• Own end-to-end CAPA lifecycle per ISO 13485 and 21 CFR 820.100.
• Drive records to due dates, reduce cycle time, and manage blockers.
• Lead structured root cause investigations using 5 Whys, Fishbone, 8D, DMAIC.
• Author high-quality CAPA reports for FDA/notified body/audit reviews.
• Ensure GDP-compliant, traceable eQMS entries.
• Collaborate with Manufacturing, Operations, R&D and Supplier Quality.
• Define and execute effectiveness checks with data analysis and status reports.

Skills

CAPA process

Root cause analysis

FDA compliance

Statistical methods

Education

Bachelor's degree in engineering

Tools

eQMS TrackWise

GxP systems

Job description

Intellectt Inc in Draper, UT is seeking a CAPA specialist to own the end-to-end CAPA lifecycle, from issue assessment to effectiveness check, ensuring ISO 13485:2016 and 21 CFR 820.100 compliance. You will drive records to due dates, perform structured root cause analyses, and author investigation reports that withstand audits.

Preference for eQMS experience and implantable device background. Bachelor's degree in engineering required; collaborate with manufacturing, operations, R&D, and supplier