PRINCIPAL SCIENTIST, NPI / LCM QUALITY Job in Irvine, California US
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson Johnson's Family of Companies, is currently recruiting for a Principal Scientist, NPI/LCM Quality, 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 Principal Scientist will provide global Quality Engineering technical leadership and guidance to the Design and Development of New and Modified Products and Processes. He/ She will provide constructive technical challenge to the design and development of a product or process to drive better product or process performance. The qualified candidate will ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes. This person will provide problem solving techniques including root cause analysis and cause and effect analysis and ensure robust processes are transferred to Manufacturing. The Principal Scientist will identify opportunities to continuously improve quality, cost and time factors, consistent with business objectives.
The Principal Scientist will develop, apply, revise and maintain quality standards for new or modified ASP Hand Hygiene products, Biocide (such as, CIDEX® Family of Products ) and Assurance Devices (such as, Biological Indicators, Color Indicator). He/ She will be providing Quality System Regulatory interpretation, consulting, training, and assessment to ensure product teams are aligned with current regulatory requirements, standards, and current industry trends. The qualified candidate will provide constructive technical challenge to the design and development of a product or process to drive better product or process performance and project outcomes. He/ She will ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes. This person will lead project teams to utilize risk management and process excellence tools and effectively drive reasonable and appropriate risk controls. The Principle Scientist will provide Advanced Statistical Analysis support and utilize various Statistical Analysis techniques and tools and conduct or support failure and complaint investigations. He/ She will initiate and support continuous process improvements within area of responsibility, and conduct supplier quality system and product audits as needed. This person will serve as the technical expert for the organization (worldwide) in the application of advanced theories, concepts, principles, and processes for an assigned area of responsibility. He/ She will supervise and provide guidance to quality engineers or technicians on particular projects and provide leadership that ensures Quality program initiatives are aligned with the business' needs. The successful candidate will lead a high performance team and drive performance results and work with core teams and development partners to ensure robust design quality practices are embedded and applied. He/She will lead continuous improvement of the new product development processes and procedures and demonstrate the ability to integrate reliability techniques as a part of product development or design changes. This person will also serves as the technical subject matter expert and communicates to auditors and investigators.
Qualifications
A B.S. in Biochemistry or Biomedical Engineering or equivalent discipline with 12 or more years of related experience OR a Master's degree in Biochemistry or Biomedical Engineering or equivalent discipline plus 10 or more years of related experience OR Ph.D. in Biochemistry or Biomedical Engineering or equivalent discipline and 7 or more years of related experience is required. Strong Quality Engineering skills with working knowledge of product design verification, as well as product and process validation activities highly desired. Experience in a FDA regulated environment is required. Leadership ability in developing achievable high-quality product requirements for products in partnership with various departments, such as, RD, Operation, Service etc. and managing the implementation and execution of these product quality goals is preferred. Prior experience in scientific research and/or analytical chemistry is highly desired. Proficiency with the Microsoft office products (MS Word, Excel etc) is required. Working knowledge of Statistical Analysis Software tools, such as MiniTab is preferred. Excellent written and verbal communication skill and ability to work independently and in a team setting and the ability to work and communicate in a cross-cultural environment is required. Leadership ability in using problem solving techniques including root cause analysis and cause and effect analysis is required. This position will require up to 15% domestic and/ or international travel. This position is based in Irvine, California.
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