CAPA Lead - (Job Number: 0809220)

CAPA Lead - (Job Number: 0809220) DescriptionAdvanced Sterilization Products Division of Ethicon, Inc., a member of Johnson && Johnson's Family of Companies, is currently recruiting for a CAPA Lead 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 Capa Lead will be responsible for providing guidance and concurrence for all CAPA related activities and ensure that appropriate corrective and/or preventative actions are implemented in a timely manner and to complete all associated documentation for the CAPA record as established by CAPA policies and procedures. This individual will provide guidance and works directly with CAPA owners for completeness compliance and closure of CAPA records and review and provide concurrence on CAPA records. This individual will be responsible for compiling CAPA metric data for all metric review meetings and dashboards as needed. This individual will manage of the day-to-day activities for the CAPA process and maintain and improve all CAPA related procedures and work instructions. This individual will create, review and communicate CAPA monitoring activities and provide risk assessment and contingency planning for CAPA monitoring activities. This individual will identify and bridge skill gaps within the group. This individual will participate in recruitment of CAPA Engineers and Technicians for CAPA ownership. This individual will mentor and coach CAPA Engineers and Technicians. This individual will elevate severe issues that may impact the health and safety of users to management immediately and recommend action items, tracking follow-up action items. This individual will oversee overall compliance to all CAPA related activities. BS in any related engineering discipline is required. MS in related engineering discipline preferred. A minimum of 5 years QA/ QC experience is required. Experience in Medical Device Pharma or other FDA regulated industry is required. A minimum of 1 to 3 years CAPA systems experience is preferred. Experience using Six Sigma methodologies, tools and Green Belt certification preferred. An ASQ Certification would be preferred. This position will be based in Irvine and will require 10% travel. If you want to explore the many small-company environments behind the big-company impact of the Johnson && Johnson Family of Companies, bid on this position today! Apply Now