Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Quality Engineer, located in Irvine, CA.
ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj .
The Senior Quality Engineer- will provide engineering support in the development and maintenance of company's quality systems. She/ He will perform investigations relating to root cause of customer complaints, and propose and implement corrective and preventative actions as required. Under general supervision, the Sr. Engineer will investigate customer complaints regarding product design, product manufacture, and product testing. The Sr. Quality Engineer will participate in projects that improve the complaint process and reduces overall customer issues, will participate in design evaluations (FMEAs), in process evaluations (PFMEAs) and in Human Factors evaluations (Health Hazards and System Risk). Further, this individual will devise and implement methods and procedures for inspecting, testing and evaluating product. She/ He will determine and implement solutions to customer issues. The Sr Quality Engineer will participate in the training of new and lower level quality engineers, provide imaginative, thorough and practical solutions to a wide range of difficult problems and provide support during External and Internal Audits of the Customer Quality process. Erroneous decisions or recommendations or failure to achieve results might cause delays in implementing CAPAs and increase the quantity of complaints resulting in customer dissatisfaction.
A Bachelor of Science degree in a technical field (for example, Electrical Engineer, Mechanical Engineering, Statistics, Computer Engineering, Chemical Engineering, Chemistry, Biology etc) with at least 5 years experience in a quality or technical field OR a Bachelor of Arts degree with at least 10 years experience in a quality or technical field OR a Masters degree with at least 3 years in a quality or technical field is required. Ability to read and understand electrical and mechanical schematics is required. Working knowledge of Digital Multimeter, Data Capture, and other electronic instrumentation and tooling will be a preference. Working knowledge of how to use measurement tools including calipers, force gauges, micrometers and other mechanical instrumentation and tooling is desired. Ability to troubleshoot electro-mechanical systems is required. Demonstrated ability to work effectively with cross-functional teams is required, preferably for complaint investigation, root cause analysis, identification and implementation of CAPAs. Ability to effectively prioritize and manage multiple activities and responsibilities is required. An understanding of statistics and how to utilize them in data analysis is required. Understanding of Failure Modes and Effects Analysis is required. Understanding of Fault Tree Analysis would be a plus. Experience in a Quality functional area with competency in Quality System Regulations is required. Experience with the application of systemic and investigative tools to evaluate product quality attributes and failure modes is required. Investigative tools such as Pex, Six Sigma, SPC, and Pareto Charting would be a preference. Broad based technical knowledge and skills in diverse areas of business a plus (i.e. Operations, R&D, Field Service) would be desired. Understanding of basic office software tools including Excel, Word, Visio is required. The ability to write and communicate clearly is required. It would be preferred that the candidate have an understanding of Human Factors and Health Hazard risks, Six Sigma (Green Belt or Black Belt) tools, training or certification, a CQA (Certified Quality Auditor) or CQE (Certified Quality Engineer) and experience with FDA auditors.
This position may require extended periods of walking, standing and/or sitting, and will require the ability to adhere to all safety requirements. This position may require up to 10% domestic and/ or international travel. This position will be based in Irvine, CA.
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