Quality Engineer (CAPA)

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

Job summary

Infosoft Inc. is seeking a Quality Engineer specializing in CAPA to lead investigations and drive corrective actions in a regulated environment.

You will own CAPAs end-to-end, from issue assessment through containment, root cause, action plans, and verification, ensuring ISO 13485 and FDA/GDP requirements are met. Responsibilities include leading cross-functional teams on floor corrections, maintaining compliant documentation, and applying statistical methods for effectiveness checks.

Qualifications

• Lead CAPA investigations and issue resolution per ISO 13485:2016 and 21 CFR 820.100.
• Document conclusions with defensible technical rationale for FDA/notified body audits.
• Ensure complete, traceable CAPA records in the eQMS with GDP adherence.
• Coordinate with Manufacturing, Operations, R&D and Supplier Quality on corrective actions.
• Apply statistical techniques and trend analysis to verify effectiveness of CAPAs.

Responsibilities

• Own assigned CAPAs from assessment to containment, root cause, action plan, and closure.
• Drive on-time completion of records and reduce cycle time and aging.
• Prepare audit-ready CAPA documentation and investigation reports.
• Support updates to SOPs, work instructions, and inspection methods post-CAPA.
• Contribute to CAPA Review Board presentations with status updates.

Skills

CAPA management

Root cause analysis

Data analysis

Technical writing

Cross-functional teamwork

Regulatory knowledge

Tools

eQMS TrackWise

eQMS Agile

eQMS Veeva

Job description

Our Client is a Global medical device Manufacturer.

We are looking for a 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, expedite 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.