Senior Quality Engineer (CAPA)

Infosoft Inc.; Draper (UT); On-site; USD 76,000 - 80,000; Full time

Job summary

Infosoft Inc. in Draper, UT, seeks a Senior Quality Engineer (CAPA) for a 12-month assignment with a pay rate of $55–$58.27 per hour.

You will own CAPAs end-to-end, drive root-cause investigations, and ensure ISO 13485 and 21 CFR 820.100 compliance while coordinating with cross-functional teams. The role requires strong technical writing, expertise with eQMS systems, and the ability to apply statistical methods and trend analysis to verify effectiveness.

Qualifications

• Strong CAPA management experience.
• Proficient in root cause investigations (5 Whys, Fishbone, FTA, 8D/DMAIC).
• Solid regulatory compliance knowledge (FDA, ISO 13485).
• Skilled in statistical analysis and data trend evaluation.
• Able to collaborate across Manufacturing, Operations, R&D and Supplier Quality.

Responsibilities

• Own CAPAs from issue assessment to closure per ISO 13485 and 21 CFR 820.100.
• Lead structured root cause investigations and document conclusions with rationale.
• Draft investigation reports and CAPA documentation for FDA/Notified Body audits.
• Ensure eQMS documentation is complete, accurate, and traceable (GDP).
• Support updates to SOPs, forms, DHRs, and inspection methods.
• Collaborate with floor teams to implement corrective/preventive actions.
• Define and execute effectiveness checks with statistical trend analysis.

Skills

CAPA management

Root cause analysis

Regulatory compliance

Statistical analysis

Cross-functional collaboration

Quality systems

Tools

TrackWise

Agile

Veeva

Job description

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, 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.