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Publicado: lunes, 9 de enero de 2017, 9:43 a. m.

"Johnson & Johnson companies are equal opportunity employers" Company: Ethicon, Inc., a Johnson & Johnson company, is a trusted, world-wide leader in medical devices company who contributes to the advance surgery and improves lives every day. We are qualified as one of the top best place to work. Joining ETHICON is more than joining a great company, it means being a part of a legacy of innovation, development and philanthropy. For more information, visit Searching the best talent for: QUALITY SYSTEMS MANAGER Main responsibilities Responsibilities: Responsibilities may include, but are not limited to: Summary: Under the direction of the Plant QA Manager, the NCR / CAPA Site Leader ensures the plant NCR and CAPA processes and structures meet all business and regulatory requirements. The NCR / CAPA Site Leader is responsible for the overall management and effectiveness of the site NCR and CAPA programs including: Administration of the NCR and CAPA systems, facilitation of the local CAPA review board, coordination and support of CAPA project teams, data trending and NCR/CAPA reporting and communication with management, team leaders, and auditing bodies. The NCR / CAPA Site 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 NCR and CAPA processes. Essential functions: • Manage the NCR and CAPA processes and systems for the site. • Represent the site on the world wide NCR and CAPA teams. • Work effectively with other NCR / CAPA site leaders to ensure consistent systems and processes at Ethicon plants. • Drive the improvement and development of NCR and CAPA system for the facility. • Responsible for the overall management and effectiveness of the NCR and CAPA processes, including leading and facilitating of relevant data review forums. • Provide education and mentoring as needed regarding NCR and CAPA (beginners and continuous education). • Develop and implement measures to monitor the effectiveness of the NCR and CAPA systems. • Lead quality systems and compliance improvement, which result from Internal / External Audits, Management Review and / or any other CAPA / NCR system indicator. • Serves as the initial point of contact for Product Complaints / Product Quality issues and ensures Risk Assessment is timely and adequately addressed. • Support site risk management process. • Oversees the complaint product evaluations activities for the site, and 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 NCR and CAPA processes and directed inspections. • Actively participates in Management Review. • Facilitates and leads the plant CAPA Review Board. • Report NCR and CAPA 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 NCR's and CAPA 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 CAPA process and CAPA system 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 NCR/CAPA system, to include monitoring and ensuring Due Date Adherence. • Leverage Process Excellence tools to effectively implement CAPA 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. • Works with CAPA team leaders to charter new CAPA's. • Provides guidance to team leaders and approvers and reviews all CAPA's to ensure documentation is complete before CAPA closure. • Communicate with NCR / CAPA leaders globally to ensure alignment, resolve problems, and share best practices. • Supports the continuous improvement of the CAPA process and computer system. • 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. Disclaimer: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Reporting to: Plant Quality Assurance Manager Qualifications EDUCATION AND JOB EXPERIENCE REQUIREMENTS: • 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 • 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. • Physical Demands: Normal office environment, mental efforts. • Work Environment: Frequent travel, Flexible to work on different shifts. • Contacts: Frequent contact with Ethicon facilities and Executive Management required. Global Leadership Profile Competencies Integrity and Credo-based Actions ~ lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent. Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed Organization Ethicon Independencia Submit your resume until: enero 13, 2016 Primary Location Mexico-Chihuahua-Juarez Organization E.E.S., S.A. de C.V. Mexico (8283) Job Function Quality Systems

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