Quality Engineer II — Medical Device Validation & CAPA

Hydrogen UK Ltd; Draper (UT); On-site; USD 51,000 - 58,000; Part time

Job summary

Hydrogen UK Ltd is seeking a QUALITY ENGINEER II to support quality assurance and manufacturing activities in a regulated medical device environment in Draper, Utah. This 9-month contract role emphasizes compliance, validation, and continual improvement.

You will lead and assist with IQ, OQ, PQ, and TMV protocols, investigate nonconformances, drive CAPA actions, perform risk assessments, and collaborate with Manufacturing, Regulatory Affairs, and Quality teams to reduce defects and ensure

Qualifications

• Bachelor's degree in Engineering required.
• 2–4 years of relevant quality engineering experience required.
• Experience in a regulated medical device manufacturing environment preferred.
• Experience with CAPA, NCR, nonconformance investigations, risk management, and change control preferred.
• Familiarity with FDA, ISO 13485, GMP, and Quality Management System requirements preferred.

Responsibilities

• Lead and support IQ/OQ/PQ/TMV validation protocols and reports.
• Ensure validation activities meet FDA/ISO 13485/GMP and internal quality requirements.
• Investigate product and process nonconformances and perform root-cause analysis.
• Author, review, and maintain NCR, CAPA, deviation, validation, and technical documentation.
• Facilitate CAPA investigations and verify effectiveness of corrective actions.
• Support Manufacturing, Engineering, and Supplier Quality in resolving quality issues and reducing defects.
• Participate in risk management activities including PFMEA and risk assessments.
• Review and approve changes through change control processes.

Skills

IQ/OQ/PQ/TMV

CAPA investigations

FDA 21 CFR Part 820

ISO 13485 / GMP

Statistical analysis (SPC/Minitab)

Documentation & writing

Education

Bachelor's degree in Engineering

Tools

Minitab

Gage R&R

DOE

Job description

Hydrogen UK Ltd is seeking a QUALITY ENGINEER II to support quality assurance and manufacturing activities in a regulated medical device environment in Draper, Utah. This 9-month contract role emphasizes compliance, validation, and continual improvement.

You will lead and assist with IQ, OQ, PQ, and TMV protocols, investigate nonconformances, drive CAPA actions, perform risk assessments, and collaborate with Manufacturing, Regulatory Affairs, and Quality teams to reduce defects and ensure