Quality Systems Manager

**Job Function**:Quality**Job Sub**Function**:Quality Systems**Job Category**:People Leader**All Job Posting Locations**:Ciudad Juarez, Chihuahua, MexicoManages a team of individual contributors and/or Supervisors, and is accountable for conducting effective performance management.Develops tactical and operational plans to implement strategies designed to ensure Quality Systems are in line with internal best practices and in compliance with the organization's Quality Assurance (QA) standards, international standards, and government regulations.Directs processes that ensure effective deployment and monitoring of Quality Systems.Benchmarks policies that define internal audit parameters, closed-loop feedback processes, and corrective and preventive actions against external and competitive organizations for continuous improvement.Coordinates with multiple functions on overall Quality Systems strategy, updates, and processes.Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within established timelines and budgets.Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision making.**About MedTech**Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.**About Cardiovascular**Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.Are you passionate about improving and expanding the possibilities of Cardiovascular?Ready to join a team that's reimagining how we heal?Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke.You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.**We are searching for the best talent for QUALITY SYSTEMS MANAGER to be in Ciudad Juarez, Mexico.****JOB SUMMARY**The Quality Systems Manager ensures that the NCR, CAPA processes, Document Control, RecordManagement and of the plant achieve the business and regulatory requirements.He/she is responsiblefor the general administration and effectiveness of the NCR and CAPA programs, including: theadministration of the Document Control systems, Record Management, the facilitation of the local CAPAReview Board, NCR and Management Review, the coordination and support to the CAPA project teams,trends data and NCR / CAPA reports and the communication with functional leaders.The QualitySystems Manager is a position that influences within the organization, employing effectivecommunication team work skills to drive results and ensure the viability of the NCR and CAPA processes.He/she serves as a representative of the site in global forums for the revision of the quality systeminformation.Responsible for assisting in the maintenance of the records management program.Provides support toall aspects of the archive, control a recovery of documents and information that is property of the companyor that has been published.Representative of the site or of the operative company in joint projects with J&J Medical Devices.**DUTIES & RESPONSIBILITIES**Under limited supervision and in accordance with all applicable federal, state and local laws/regulationsand Corporate Johnson & Johnson, procedures and guidelines, this position:- Administers the processes and systems of Record Management, NCR and CAPA of the siteand represents it worldwide.He/she also coordinates the local activities regarding documentcontrol.- Works effectively with the leaders of Document Control, Record Management, NCR and CAPAof other sites to ensure that the systems and processes are consistent throughout all the plants.- Is responsible of the general administration, effectiveness and monitoring of the Documentcontrol, Record Management and NCR / CAPA processes/systems.- Provides training and assistance, when necessary, in regards to Document control, RecordManagement, NCR and CAPA (for beginners and continuous training for experiencedassociates) by using excellence tools (DMAIC).- Improves and develops the Documentation Control system, Record Management, NCR andCAPA, leads the quality system, improves the compliance resulted from internal/external audits,management review and/or any other indicator of the different systems.- Plans, coordinates and directs the management review and leads the "CAPA Review Board".- Ensures that the major non-conformities, trends and near misses are escalated to themanagement and given priority according to the identified risk.- Opens new CAPAs and assigns the team leader in the computer system and obtains thenecessary resources fo the effective resolution of CAPA, including the vigilance and assuran