Sr Quality Engineer

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. #J-18808-Ljbffr Hydrogen Group