HireDiversity

Irvine, CA, US

CAPA MANAGER-00000859

Description

Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a CAPA Manager, 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 CAPA Manager, will report to the Director Quality Systems and Compliance and will provide Corrective and Preventive Action (CAPA) process leadership driving improvements in product and process performance, and elimination of waste. She/ He will be responsible for the effectiveness and efficiency of the Corrective and Preventive Action Process and System. Will develop a plan to bridge improvement gap between CAPA vision and current state, and implement the plan for an integrated CAPA process and will be the CAPA process owner, drive execution through Site CAPA Coordinators with dotted line reporting. The manager will be accountable for performance of CAPA system and metrics and will provide direction and leadership for CAPA Site Leaders resulting in each site successfully implementing, maintaining and improving the CAPA process. This individual will provide leadership with the ASP CAPA Review Board to achieve ASP quality goals, will develop and implement an ongoing education program for the CAPA process and will develop and implement measures to monitor the effectiveness of the CAPA process and drive remediation for improvement. The CAPA Manager will be responsible for supervising technical staff to ensure that objectives are met.

The CAPA Manager will be responsible for organizing and coordinating the Corrective and Preventive Action Process investigation and implementation teams for root cause analysis and corrective and preventive action. She/ He will effectively manage and improve the CAPA process and system for tracking, trending and reporting and will ensure CAPA process execution, accountability, and due diligence. The individual will ensure that trends are analyzed and CAPA's initiated and completed as required. Will be responsible for reporting on a monthly and quarterly basis against established measures and will supply the status of CAPA performance to Executive Management Review process. The manager will drive continuous improvement through the CAPA process while interfacing closely with key members of management, the CAPA Process Owners, to facilitate the effectiveness of the Corrective and Preventive Action Process. She/ He will be the process Owner for escalation of quality issues, drive process improvements and ensure execution to process. Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Qualifications


A minimum of a BA/BS degree in a Life Science, Engineering, or Physical Science is required, with an advanced degree preferred. A minimum of 5 years related experience within Quality is required. Experience in the medical device industry is required. Experience in an FDA regulated environment is required. Experience interacting with FDA , notified body auditors or other regulatory bodies and influencing Quality regulations and standards is preferred. ASQ certification (CQE, CQA & PE) is preferred. Knowledge of interpretation and application of QSR, MDD, and ISO 13485 are required. Knowledge or application of other international standards is an asset. Demonstrated expertise in interpretation and pragmatic application of QA standards is preferred. Initiative in innovative approaches to QA solutions and applications in a fast paced changing business environment is preferred. Demonstrated project management skills (leading a project in some capacity) is highly desired. The ability to continuously assess the effectiveness of functional processes and lead progressive improvement initiatives is required. Strong management and collaboration skills will be required. Experience supervising technical staff is required.

This position may require 5% travel. This position will be based in Irvine, CA.

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Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)