Onsite location: Irvine, CA
Pay: $55.00 - $59.00 per hour
Job Summary
This Pilot Operations Senior Quality Engineer role partners on the validation activities for an introducer sheath for the Transcatheter Heart Valve (THV) Business Unit.
Job Description
* Our Quality team helps shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. In this role, you will apply your IQ/OQ/PQ knowledge as well as quality engineering principles and methods to ensure compliance with regulatory requirements and company systems/procedures to deliver much needed devices to patients.
Key Responsibilities:
* Identify and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement.
* Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
* Review and approve equipment validations and asset management actions.
* Participate in validation strategy development and review the PVP/MVP.
* Ensure validation scope aligns with intended use, risk assessment, and regulatory requirements.
* Review PFMEAs and process risk assessments to verify critical process parameters (CPPs) and critical quality attributes are adequately addressed.
* Confirm prerequisite activities are complete (equipment qualification, TMV, software validation, fixture qualification, drawing release status, etc.).
* Verify statistical rationale, sampling plans, and acceptance criteria are appropriate.
* Develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team
* Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
* Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
* Other incidental duties assigned by Leadership
Education and Experience:
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All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.