Quality Engineer (CAPA)

Infosoft Inc.; Draper (UT); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Infosoft Inc. in Utah is seeking a Quality Engineer (CAPA) to own CAPA records from issue assessment through containment, root cause, action plans, and effectiveness verification, in compliance with ISO 13485:2016 and 21 CFR 820.100.

You will lead investigations and document conclusions with defensible technical rationale. The role requires collaboration with Manufacturing, Operations, R&D, and Supplier Quality on the floor to implement corrective actions, perform effectiveness checks with

Qualifications

• Experience leading CAPA investigations and documenting conclusions.
• Proven ability to withstand FDA/notified body audits with strong technical writing.
• Knowledge of ISO 13485:2016 and 21 CFR 820.100.

Responsabilités

• Own assigned CAPAs from issue assessment to closure.
• Lead root cause investigations using 5 Whys, Ishikawa, and 8D/DMAIC.
• Author CAPA reports for FDA, Notified Bodies, and internal audits.
• Ensure compliant, traceable eQMS documentation with GDP adherence.
• Support SOP/work instruction updates stemming from CAPA actions.
• Collaborate with Manufacturing, Operations, R&D, and Supplier Quality on the floor.
• Define and execute effectiveness checks with statistics and trend analysis.
• Present status at the CAPA Review Board.

Connaissances

CAPA ownership

Root cause analysis

5 Whys

Fishbone/Ishikawa

8D/DMAIC

Technical writing

FDA compliance

Data trend analysis

Cross-functional collaboration

Outils

TrackWise

Agile

Veeva

eQMS

Description du poste

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, escal... [text truncated due to original input truncation]
• 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