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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