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Your unique talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech

We are searching for the best talent for QUALITY SYSTEM AND PERFORMANCE LEAD for Ethicon WCR, Ciudad Juarez.

Purpose:

Under the direction of the Site Quality Lead, the Quality Systems and Performance Leader ensures the plant quality systems processes and structures meet all business and regulatory requirements. The Quality Systems and Performance Leader is responsible for the overall management and effectiveness of the site Quality Systems programs including: Administration of the NCR and CAPA systems, facilitation of the local CAPA review board, Management Review coordination and support of CAPA project teams, Document Control, Records Management, Complaints, data trending and Quality Systems reporting and communication with management, team leaders, and auditing bodies. The Quality Systems and Performance Leader is an influential position within the Operations organization that employs effective communication, influencing, and interdependent partnering skills to drive results and ensure the viability of the quality systems processes.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Essential functions:

• 1. Manage the quality systems processes for the site.

• 2. Represent the site on the world-wide NCR and CAPA teams.

• 3. Work effectively with other Quality Systems and Performance Lead to ensure consistent systems and processes at Ethicon plants.

• 4. Drive the improvement and development of quality systems for the facility.

• 5. Responsible for the overall management and effectiveness of the Quality Systems processes, including leading and facilitating of relevant data review forums.

• 6. Provide education and mentoring as needed regarding Quality Systems (beginners and continuous education).

• 7. Develop and implement measures to monitor the effectiveness of the Quality Systems.

• 8. Lead quality systems and compliance improvement, which result from Internal / External Audits, Management Review and / or any other Quality Systems indicator.

• 9. Serves as the initial point of contact for Product Complaints / Product Quality issues and ensures Risk Assessment is timely and adequately addressed.

• 10. Support site risk management process.

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• 11. Maintains track and trending of product performance / results of product evaluations for escalation to CAPA.

• Other Responsibilities:

• Participates as a key member in both external and internal audits and is responsible for the local Quality Systems processes and directed inspections.

• Facilitates and leads the plant CAPA Review Board, Quality Process Review and Management Review.

• Report Quality Systems results / metrics to the Plant QA Manager and Management staff as applicable and makes recommendations for improvement.

• Partner with management to develop and implement meaningful trending of Quality Systems performance.

• Ensure major non-conformances, trends, and near misses are escalated to management and prioritized commensurate with risk.

• Lead major issues, when appropriate.

• Responsible for ongoing Quality Systems training (beginners and continuing education for experienced associates.)

• Opens new CAPA's and assigns the team leader in the computer system.

• Ensure the appropriate resources are assigned and held accountable for nonconformance resolution and CAPA effectively.

• Work with team leaders to establish and track an effectively measure for each CAPA.

• Manage the Quality Systems, to include monitoring and ensuring Due Date Adherence.

• Leverage Process Excellence tools to effectively implement Quality Systems improvements using a DMAIC approach.

• Responsible to mentor both technical and non-technical resources in investigation, troubleshooting, escalation, and resolution of product and process quality issues, NCR and CAPA.

• Provides guidance to team leaders and approvers and reviews all CAPA's to ensure documentation is complete before CAPA closure.

• Communicate with Quality Systems Manager globally to ensure alignment, resolve problems, and share best practices.

• Supports the continuous improvement of the Quality Systems process.

• Partner with IM and the data warehouse team to drive improvements in business intelligence to facilitate effective tracking and trending.

• Perform other work-related duties, as assigned by site management.

• Strategic Plan & Long-Range Financial Planning including BP/JU/NU

• Goal and Objectives/Quality Planning

• Business Portfolio Management (Capital, OPEX and Cost Actions)

• CIP and Project Portfolio Management

• SCQ Reviews

o Responsible for communicating business related issues or opportunities to next management level

o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

o For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

o Performs other duties assigned as needed

Qualifications / Requirements:

• From 8 to 10 years of overall experience.

• Minimum 5 years’ experience in Operations, Engineering and/or Quality Assurance is required.

• Background in Medical Device Industry, preferred

• Experience leading CAPAs is an asset

• Bachelor’s degree is required, with a degree in Engineering, Science or related discipline preferred

• advanced degree is preferred.

• Knowledge of regulatory requirements (ISO, QSR, etc.), preferred

• Experience with external auditing bodies, preferred

• Process Excellence Green Belt Certification with demonstrated problem-solving and statistics skills, preferred

• Demonstrated project management skills with strong results orientation, required.

• Strong communication, influencing and presentation skills, required.

• Bilingual, fluent in English and Spanish.