STAFF QUALITY ENGINEER Job in Irvine, California US
Advanced Sterilization Products, a member of Johnson Johnson's Family of Companies, is recruiting for a Staff Quality Engineer, located in Irvine, CA.
Advanced Sterilization Products (ASP) Division of Ethicon, Inc. is a leading innovator of technologies in the areas of sterilization, high level disinfection, cleaning of medical devices, and hand hygiene. ASP markets STERRAD® Systems, the CIDEX® Family of Products, and PREVACARE® Antimicrobial Hand Gel. The company is focused on hospitals and surgery centers.
The Staff Quality Engineer will support capital equipment and other products manufacturing. The individual will be proficient in the understanding of regulatory requirements for medical devices and will demonstrate proficiency with statistical methods, sampling, design of experiments, process capability analysis, FMEA, and FTA hazard analysis . She/ He will, using Six Sigma methodology, be able to perform process variability studies, risk analysis and test method variability, will review and approve validation and qualification protocols and support the execution of process / product qualifications validations (IQ, OQ, PQ). The Engineer will provide support to develop and maintain documentation to support the validation process, specifications, manufacturing and test procedure and will participate and collaborate with supply chain, RD engineering, operations engineering and manufacturing to identify potential areas of process variability, address root causes and implement improvements.
The Staff Quality Engineer will lead the process that monitors manufacturing improvements to measure their effect on the process and/or product, will participate in preparation of process/ Design Failure Mode and Effects Analysis (FMEA) and will provide technical support to other Engineers. She/ He will provide their expertise and experience with general manufacturing processes for Medical Device Capital Equipment or Medical Devices and will be knowledgeable of non conformance systems and of the requirements for first article inspection, incoming, in process inspections, and lot release testing, including sampling strategies and test methods. She / he will provide expertise on FDA Quality Systems regulations, and ISO 13485. The ideal candidate will posses leadership skills and will have a strong electrical engineering or mechanical engineering background in Medical Device Capital Equipment or Medical Devices, will be responsible for resolving Manufacturing and Supplier related issues of Medical Device Capital Equipment or Medical Devices and will devise and implement methods and procedures for inspecting, testing and evaluating production. Will provide technical QA support to assigned inspection and manufacturing area(s). Further, this position will require a wide application of principles, theories and concepts in the field, plus a working knowledge of other related disciplines. The Staff Quality Engineer will participate in process evaluations (e.g. FMEA's), develop and execute manufacturing process valuations, will determine appropriate sampling plans for subsequent routine production and will participate in the training of new and lower level quality engineers.
Qualifications
A minimum of a BS degree with a minimum of 6 years related experience OR a minimum of a MS degree with a minimum of 4 years related experience OR a PhD with a minimum of 2 years related experience is required. A degree in Electrical Engineering (EE), Mechanical Engineering (ME) or Microbiology will be given preference. Experience in a FDA regulated environment preferred. Experience with Medical Devices highly desired. Experience with non-conformances. FMEAs, and CAPAs is required. Working knowledge of first article inspection, in-coming/ in-process inspections, lot release testing and sampling plans required. Prior experience with FDA audits would be a plus. Experience working with cross functional teams such as Engineering, Operations, Supply Chain, Suppliers, New Product Development etc, is desired. Experience with reading and interpreting mechanical drawings preferred. Ability to lead and/ or mentor others highly desired. Any quality related certifications or trainings would be a preference.
This position may require up to 10% domestic travel. This position will be based in Irvine, CA.
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