What are the responsibilities and job description for the Senior Quality Engineer (CAPA) position at Infosoft, Inc.?
Job Title: Senior Quality Engineer (CAPA)
Pay Rate: $55 to $58.27/HR
Duration: 12 months
Location: Draper, UT
Our Client is a Global medical device Manufacturer.
We are looking for a Senior Quality Engineer (CAPA).
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, escalate 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.
Requirements:
- Bachelor's degree in engineering required.
- 5-7 years of experience required.
Salary : $55 - $58