Senior CAPA & Quality Improvement Engineer

Intellectt Inc; Draper (UT); On-site; USD 95,000 - 120,000; Full time

Job summary

Intellectt Inc in Draper, UT, seeks a CAPA specialist to own the end-to-end CAPA lifecycle, from issue assessment to effectiveness verification, in compliance with ISO 13485:2016 and 21 CFR 820.100. This role demands rigorous documentation and cross-functional collaboration to drive timely corrective actions.

You will lead root cause analyses (5 Whys, Ishikawa, 8D/DMAIC), author investigation reports, and ensure GDP-compliant records in the eQMS, with preference for TrackWise, Agile or Veeva

Qualifications

• Bachelor's degree in engineering is required.
• Experience with ISO 13485 and FDA/Quality systems is preferred.
• CQA/CQE or equivalent certification is a plus.

Responsibilities

• Take ownership of CAPAs from issue assessment to closure.
• Lead root cause investigations using 5 Whys, Ishikawa, 8D/DMAIC.
• Prepare high-quality CAPA and investigation reports.
• Maintain compliant, traceable eQMS entries with GDP adherence.
• Collaborate with Manufacturing, Operations, R&D and Supplier Quality.

Skills

Quality systems

Root cause analysis

Cross-functional collaboration

Statistical techniques

Education

Bachelor's degree in engineering

Tools

TrackWise

Agile

Veeva

8D/DMAIC

Job description

Intellectt Inc in Draper, UT, seeks a CAPA specialist to own the end-to-end CAPA lifecycle, from issue assessment to effectiveness verification, in compliance with ISO 13485:2016 and 21 CFR 820.100. This role demands rigorous documentation and cross-functional collaboration to drive timely corrective actions.

You will lead root cause analyses (5 Whys, Ishikawa, 8D/DMAIC), author investigation reports, and ensure GDP-compliant records in the eQMS, with preference for TrackWise, Agile or Veeva