SENIOR QUALITY ENGINEER - PILOT OPERATIONS IRVINE, CA SCHEDULE

Standard

DURATION

9

Month Contract PAY:

$54-59/hr.

Job Responsibilities:

In this role, you will support validation activities and quality engineering initiatives for an introducer sheath within the Transcatheter Heart Valve (THV) Business Unit.

Key responsibilities include:

• 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.
• 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.

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