Quality Engineer II

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

QUALITY ENGINEER II

LOCATION: Draper, UT
SCHEDULE: Standard
DURATION: 9-Month Contract
MAX PAY RATE: $37-42/hr.

Job Responsibilities

In this role, you will support quality assurance and manufacturing quality activities within a regulated medical device environment. Key responsibilities include:

• Supporting equipment, process, and test method validation activities, including IQ, OQ, PQ, and TMV.
• Conducting root cause investigations and supporting nonconformance and CAPA activities.
• Ensuring products and processes comply with applicable FDA, ISO 13485, GMP, and internal Quality Management System requirements.
• Supporting manufacturing, engineering, supplier quality, regulatory, operations, and quality teams in resolving quality issues.
• Analyzing quality and manufacturing data to identify trends, recurring defects, and opportunities for improvement.
• Supporting continuous improvement initiatives focused on process capability, defect reduction, compliance, and operational excellence.

Essential Duties and Job Functions

• Lead and support equipment, process, and test method validation activities, including development, execution, and approval of IQ, OQ, PQ, and TMV protocols and reports.
• Ensure validation activities are performed in accordance with FDA, ISO 13485, GMP, and internal quality requirements.
• Investigate product and process nonconformances and perform root cause analysis using methodologies such as 5 Why, Fishbone, Fault Tree Analysis, and other quality tools.
• Author, review, and maintain NCR, CAPA, deviation, validation, and technical documentation.
• Facilitate CAPA investigations, identify corrective and preventive actions, and verify the effectiveness of implemented solutions.
• Support Manufacturing, Engineering, and Supplier Quality teams in resolving quality issues and reducing recurring defects.
• Participate in risk management activities, including PFMEA reviews, risk assessments, and implementation of risk mitigation strategies.
• Analyze quality and manufacturing data using statistical techniques to identify trends, adverse conditions, and process improvement opportunities.
• Support internal and external audits and regulatory inspections by providing technical documentation and evidence of compliance.
• Review and approve changes through change control processes and assess potential quality impacts to validated systems and processes.
• Develop and revise quality procedures, work instructions, validation plans, and related Quality Management System documentation.
• Drive continuous improvement initiatives focused on process capability, defect reduction, compliance, and operational excellence.
• Provide quality engineering support for new product introductions, manufacturing transfers, and process improvements.

Knowledge & Skills

• Hands-on experience executing and documenting IQ, OQ, PQ, and TMV activities.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and medical device quality system requirements.
• Experience conducting and documenting root cause investigations and implementing effective CAPAs.
• Working knowledge of NCR, CAPA, change control, deviation, and risk management processes.
• Understanding of validation lifecycle management, including protocol development, execution, and report generation.
• Working knowledge of statistical analysis tools and quality methodologies, including SPC, Minitab, DOE, Gage R&R, and process capability analysis.
• Experience with PFMEA, risk assessments, and structured problem-solving methodologies.
• Proficiency in reviewing technical drawings, specifications, procedures, and validation documentation.
• Strong technical writing and documentation skills.
• Excellent verbal and written communication skills.
• Strong organizational skills with the ability to manage multiple priorities and projects.
• Detail-oriented with a strong commitment to compliance and product quality.
• Ability to independently manage investigations, validations, projects, and quality system activities.
• Ability to build productive working relationships across Manufacturing, Engineering, Quality, Regulatory Affairs, and Operations.
• Strong teamwork, problem-solving, analytical, and critical-thinking skills.

Education & Experience

• 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 equipment, process, and test method validation 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.