Senior Engineer

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

Contract: 12+ months with Possible extension.

Summary

Take personal ownership of assigned individual CAPAs and all related processing — from issue assessment and containment through root cause, action plan execution, implementation verification, and effectiveness check closure — in compliance with ISO 13485:2016 (Clauses 8.5.2/8.5.3) and 21 CFR 820.100.

• Support overall CAPA process acceleration: drive assigned records to committed due dates, reduce cycle time and aging, elevate blockers early, and hold cross-functional task owners accountable.
• Lead structured root cause investigations using 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis, and 8D/DMAIC, documenting conclusions with clear, defensible technical rationale.
• Author high-quality investigation reports and CAPA documentation that withstand FDA, Notified Body, and internal audit scrutiny — strong technical writing is a core requirement of this role.
• Ensure documentation compliance across all assigned records: complete, accurate, traceable, and contemporaneous entries in the eQMS, with full data integrity and GDP adherence.
• Support Quality System updates and modifications, including revisions to SOPs, work instructions, forms, DHRs, and inspection methods resulting from CAPA actions.
• Partner with Manufacturing, Operations, R&D, and Supplier Quality on the floor to implement corrections and corrective/preventive actions, and confirm actions do not adversely affect finished product or patient safety.
• Define and execute effectiveness check methodology, applying statistical techniques and trend analysis of NC, complaint, and audit data to confirm sustained resolution; present record-level status at the CAPA Review Board.

Preferred: eQMS experience (TrackWise, Agile, Veeva, or equivalent), Class II/III implantable or combination device experience, CQE/CQA.

Education/Experience

• Bachelor's degree in engineering required.