Sr Quality Engineer

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

SENIOR QUALITY ENGINEER - PILOT OPERATIONS

IRVINE, CA

Schedule: Standard

Duration: 9 Month Contract

Pay: $54-59/hr.

Job Responsibilities:

• Supporting validation activities for medical device manufacturing processes and equipment.
• Applying quality engineering principles and methods to ensure compliance with regulatory requirements and company quality systems.
• Optimizing complex manufacturing processes using engineering methodologies such as Six Sigma, TOPP, and Lean.
• Collaborating with cross-functional teams to develop validation strategies, assess risks, and support continuous process improvement.
• Ensuring validation activities align with intended use, risk assessments, and applicable regulatory requirements.

Essential Duties and Job Functions:

• Participate in the development and review of validation strategies, including PVP/MVP documentation.
• Review and approve equipment validations and asset management activities.
• Identify opportunities to redesign or improve equipment, tools, fixtures, and manufacturing processes to reduce risk and improve efficiency.
• Review PFMEAs and process risk assessments to verify critical process parameters (CPPs) and critical quality attributes (CQAs) are adequately addressed.
• Verify completion of prerequisite activities, including equipment qualification, test method validation (TMV), software validation, fixture qualification, and drawing release.
• Review statistical rationale, sampling plans, and acceptance criteria to ensure they are appropriate for validation activities.
• Develop, update, and maintain technical content for risk management files.
• Review and revise process FMEAs in collaboration with cross-functional and business unit teams.
• Apply quality engineering principles to support product development, manufacturing, and continuous process improvement.
• Develop training and documentation materials, including work instructions, to support production and knowledge transfer.
• Assign support tasks and provide direction to technicians conducting validation and testing activities.
• Train technicians, provide feedback, and coordinate technician activities as required.li>
• Ensure adherence to applicable quality systems, company procedures, regulatory requirements, and safety standards.

Knowledge & Skills:

• Strong documentation, communication, and interpersonal relationship skills.
• Strong understanding of statistical techniques and their application in quality engineering.
• Working knowledge of IQ/OQ/PQ and equipment/process validation principles.
• Experience working with laboratory and industrial equipment.
• Substantial understanding of engineering principles, theories, and concepts.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Thorough understanding of manufacturing processes and equipment.
• Knowledge of and adherence to quality systems and regulatory requirements.
• Strong attention to detail and accuracy.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to work effectively in cross-functional and inter-departmental teams.
• Strong leadership skills and ability to influence change.
• Ability to build and maintain productive internal and external working relationships.
• Proficiency with Microsoft Office Suite and other computer applications used in engineering and quality functions.
• Familiarity with Six Sigma, Lean, TOPP, and continuous improvement methodologies.

Education & Experience:

• Bachelor's degree in Engineering or a related field.
• 4+ years of relevant industry experience required.
• Master's degree or equivalent in Engineering or a related field with 3+ years of relevant experience preferred.
• Ph.D. or equivalent in Engineering or a related field with relevant experience preferred.
• Medical device industry experience preferred.
• Experience with quality systems, process validation, and regulatory requirements for medical devices highly desirable.
• CQE (Certified Quality Engineer), Six Sigma, or Lean Black Belt certification preferred.