Senior Quality Engineer: Validation & Process Excellence

Hydrogen Group; Irvine (CA); On-site; USD 74,000 - 81,000; Full time

Job summary

Hydrogen Group in Irvine is seeking a Senior Quality Engineer for Pilot Operations to lead validation activities for medical device manufacturing. You will support validation strategies, assess risks, and drive continuous process improvements with cross-functional teams.

The role requires strong knowledge of IQ/OQ/PQ, Six Sigma and Lean, plus experience in equipment validation and regulatory compliance. This is a 9-month contract based in Irvine, CA, paying $54–$59 per hour.

Qualifications

• Bachelor's degree in Engineering or related field is required.
• 4+ years of relevant industry experience; medical device experience preferred.
• MCQ/QA methods and validated equipment practices understood.

Responsibilities

• Support validation strategies for medical device manufacturing processes and equipment.
• Apply quality engineering principles to ensure regulatory compliance.
• Optimize manufacturing processes using Six Sigma, TOPP, and Lean.
• Collaborate with cross-functional teams to assess risks and drive improvements.
• Ensure validation activities align with use, risk assessments, and regulatory requirements.
• Develop and review validation plans, PFMEAs, CPPS, and process validation documents.

Skills

Documentation

Statistical methods

IQ/OQ/PQ

Equipment validation

Preventive action

Risk assessment

Six Sigma

Lean

Team leadership

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Master's degree preferred

Ph.D. preferred

Job description

Hydrogen Group in Irvine is seeking a Senior Quality Engineer for Pilot Operations to lead validation activities for medical device manufacturing. You will support validation strategies, assess risks, and drive continuous process improvements with cross-functional teams.

The role requires strong knowledge of IQ/OQ/PQ, Six Sigma and Lean, plus experience in equipment validation and regulatory compliance. This is a 9-month contract based in Irvine, CA, paying $54–$59 per hour.