Sr Quality Engineer

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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