QUALITY ENGINEER-0371140708
Description
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Quality Engineer, Quality Systems, 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 Quality Engineer, Quality Systems will provide quality engineering guidance and support to the Corrective and Preventive Action (CAPA) process. The Quality Engineer will collaborate with representatives from other functional areas to facilitate timely and effective Corrective and Preventive Action (CAPA) investigations, action plan implementation and effectiveness monitoring.
The Quality Engineer, Quality Systems, will serve as a CAPA Subject Matter Expert (SME) and will monitor and report Quality Management System metrics relating to the CAPA system. The individual will work on complex investigations and will coordinate technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA actions. The Quality Engineer will facilitate and, when delegated to, provide leadership for the CAPA Review Board (CRB), will provide back room support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits), and will provide training regarding CAPA-related Quality Management System Elements to representatives from other functional areas. This individual will identify opportunities to continuously improve CAPA-related quality systems and processes in alignment with overall quality and business objectives, as well as taking ownership of CAPAs impacting the CAPA Quality System. She/ he will support and participate in cross-functional projects when assigned, will facilitate technical innovations to enhance Quality Systems and support business goals and will assist with other Quality System activities as requested by management.
Qualifications
A minimum of a Bachelor's degree in a technical discipline (Math, Science, Engineering or Information Technology) is required; A degree is Engineering is preferred. A minimum of 3 years work experience is required. Experience working in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred. Specific experience in corrective and preventive action efforts is required. Working knowledge of 21 CFR Part 820 and ISO 13485 is required. Knowledge of CAPA system applications is required. Experience with EtQ Instinct CAPA module is preferred. A demonstrated proficiency in process improvement methodology and use of investigative tools (Cause and Effect Diagrams, Trend Analysis, Capability Analysis, Control Charts, Pareto Charting, etc.) are required. Broad-based technical knowledge and experience working with others in diverse areas of business (Operations, R&D, Field Service, Finance, Marketing/Sales) is required. Demonstrated ability to work effectively with cross-functional teams for problem-solving, product and process improvement is also required. This position requires the ability to effectively prioritize and manage multiple activities and responsibilities. Outstanding business and technical communication skills (verbal, written, presentation) is required. Proficiency with quality-related applications such as Minitab, Statgraphics, QI Macros, etc is preferred. Hands on experience with Risk Assessment (especially Hazard Analysis, Fault Tree Analysis, SHUMA, DFMEA, FMEA, FMECA, PFMEA), Reliability Engineering and/or Product/Process Validation are preferred.
This position will be based in Irvine, CA and will require up to 10% domestic and/ or international travel.
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J2W:LI NA
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
Job Function: Quality (Eng)
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