At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Systems **Job Category:** People Leader **All Job Posting Locations:** Ciudad Juarez, Chihuahua, Mexico **Job Description:** Manages 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. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech **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. 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 SYSTEMS MANAGER to be in Ciudad Juarez, Mexico.** **JOB SUMMARY*** The Quality Systems Manager ensures that the NCR, CAPA processes, Document Control, Record Management and of the plant achieve the business and regulatory requirements. He/she is responsible for the general administration and effectiveness of the NCR and CAPA programs, including: the administration of the Document Control systems, Record Management, the facilitation of the local CAPA Review 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 Quality Systems Manager is a position that influences within the organization, employing effective communication 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 system information. Responsible for assisting in the maintenance of the records management program. Provides support to all aspects of the archive, control a recovery of documents and information that is property of the company or 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/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: • Administers the processes and systems of Record Management, NCR and CAPA of the site and represents it worldwide. He/she also coordinates the local activities regarding document control. • Works effectively with the leaders of Document Control, Record Management, NCR and CAPA of 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 Document control, Record Management and NCR / CAPA processes/systems. • Provides training and assistance, when necessary, in regards to Document control, Record Management, NCR and CAPA (for beginners and continuous training for experienced associates) by using excellence tools (DMAIC). • Improves and develops the Documentation Control system, Record Management, NCR and CAPA, 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 the management and given priority according to the identified risk. • Opens new CAPAs and assigns the team leader in the computer system and obtains the necessary resources fo the effective resolution of CAPA, including the vigilance and assurance of the adhesion of Expiration date. • He is a mentor of the resources, technical and non-technical, in the investigation, problem resolution, scaling and resolution of quality problems in the products and processes, NCR/CAPA. • Ensures that the quality of the investigations and their closing adjust to the regulations established by the company. • Is up to date in quality control techniques and company products and their backup systems. • Management of subordinate supervisors, engineers, quality assurance engineers, he/she is responsible for the direction in general. • Performs other tasks related to the work, which will be assigned by the management of the site. Supervision Responsibilities • Authority to assign resources: all management levels have the authority to assign the direct reports and their corresponding secondary reports. • Financial authority: all administrative levels that have authorized signature to make charges while they are in compliance with the policy. To obtain detailed information, please refer to the policy. o Responsible for communicating business related issues or opportunities to next management level 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 **EXPERIENCE AND EDUCATION** * • Completed professional career. • Preferably in Engineering or Science. • Masters in an applicable area, preferably. • Minimum experience of 8 to 10 years or more in operations, engineering and/or quality control. • Experience in the medical industry, preferably. • ASQ certifications, preferably. **REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and** **AFFILIATIONS*** • Knowledge of the regulatory requirements (ISO, QSR, etc.). • Experience with the external auditing entities, preferably. • Excellence Processes Certification (Green Belt) with demonstrated abilities in problem resolution and statistics, preferably. • Demonstrate project management skills with strong results orientation. • Strong communication, influence and presentation skills. • Bilingual, fluent in English and Spanish. • Teamwork and leadership skills • Ability to effectively communicate to top management. • Ability to define problems, gather information, plan and execute objectives.