CAPA & Quality Engineer – Medical Devices (ISO 13485/FDA)

Hydrogen Group; Draper (UT); On-site; USD 90,000 - 120,000; Full time

Job summary

Hydrogen Group seeks a CAPA lead to own CAPAs from issue assessment through closure in a regulated medical device environment. You will perform structured root cause investigations, author detailed CAPA reports, and ensure GDP data integrity in the eQMS while collaborating with Manufacturing, Operations, R&D and Suppliers.

Responsibilities include accelerating CAPA timelines, conducting effectiveness checks, and presenting status at CAPA Review Boards, with a focus on compliance to ISO

Qualifications

• Bachelor's degree in Engineering.
• 5-7 years of relevant professional experience.
• Experience managing CAPAs and conducting structured root cause investigations.
• Strong technical writing and Quality System documentation skills.
• Knowledge of ISO 13485:2016 and 21 CFR 820.100.

Responsibilities

• Take ownership of CAPAs from issue assessment to closure.
• Lead root cause investigations using 5 Whys, Ishikawa, 8D.
• Author comprehensive CAPA reports for FDA/notified body audits.
• Maintain GDP and traceable records in the eQMS.
• Collaborate with Manufacturing, Operations, R&D and suppliers.
• Define and run effectiveness checks with trend analysis.

Skills

CAPA management

Root cause analysis

Technical writing

Quality systems

Statistics & trend analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

TrackWise

Veeva

Agile

Job description

Hydrogen Group seeks a CAPA lead to own CAPAs from issue assessment through closure in a regulated medical device environment. You will perform structured root cause investigations, author detailed CAPA reports, and ensure GDP data integrity in the eQMS while collaborating with Manufacturing, Operations, R&D and Suppliers.

Responsibilities include accelerating CAPA timelines, conducting effectiveness checks, and presenting status at CAPA Review Boards, with a focus on compliance to ISO