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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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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

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 surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

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 MANAGER for Ethicon Endo in Ciudad Juarez, Mexico.

Purpose:

This job description covers the knowledge, skills & abilities for the Quality Systems Manager position, Managing the NCR and CAPA processes and systems for the Manufacturing Operations sites.
Lead quality systems and compliance improvement, which result from Internal / External Audits, Management Review and / or any other CAPA / NCR system indicator.

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:

POLICIES: Know and follow EES policies and procedures; ensure that direct reports know and follow EES policies and procedures related to work activities performed in area of responsibility.
o TRAINING: Complete training in area of responsibility and ensure that direct reports are trained in area of responsibility within allowed time-period. Training is required for changes in existing policies and
procedures, for new assignments and for implementation of new policies and procedures. Complete required periodic re-training and ensure that required periodic re-training takes place for direct reports in areas such as safety and environmental.
o SAFETY: Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s
safety performance and ensure that safety is a part of each direct report’s GPMS. Provide resources (time and money) necessary to maintain safety process. Ensure safety structure is in place in form of working committees and department coordinators.
o Manage the NCR and CAPA processes and systems for the sites.
o Represent the sites on the worldwide NCR and CAPA teams.
o Work effectively with other NCR / CAPA site leaders to ensure consistent systems and processes at Ethicon plants.
o Drive the improvement and development of NCR and CAPA system for the facilities.
o Responsible for the overall management and effectiveness of the NCR and CAPA processes, including leading and facilitating of relevant data review forums.
o Provide education and mentoring as needed regarding NCR and CAPA (beginners and continuous education).
o Develop and implement measures to monitor the effectiveness of the NCR and CAPA systems.
o Lead quality systems and compliance improvement, which result from Internal / External. Audits, Management Review and / or any other CAPA / NCR system indicator.
o Serves as the initial point of contact for Product Complaints / Product Quality issues and ensures Risk Assessment is timely and adequately addressed.
o Support sites risk management process.
o Oversees the complaint product evaluations activities for the sites and maintains track and trending of product performance / results of product evaluations for escalation to CAPA.
o Establishes and maintains objectives, programs, procedures and controls to support the quality policy and mission.
o Oversee capital related projects and monitor controllable spending for the department.
o Lead or participate in regulatory agency interaction: FDA (Food & Drug Administration), TUV, J&J CQA during audits or other information inquiries.
o Provide for associate development by setting standards, managing expectations & coordinating training programs.
o Evaluate and recommend staffing requirements to ensure maximum utilization of personnel to fulfill department objectives.
o Assist with problem solving, decision-making & conflict resolution through coaching & counseling.
o Partner with cross-functional leaders to meet goals and objectives.
o Assure that EES and its internal manufacturing facilities, component suppliers & external manufacturers have strong, capable quality systems & are in compliance with government & corporate regulations.
o Lead efforts to increase the proficiency (skills and knowledge) of the organization through attainment of PE, and professional certifications.
o Assist w/Managing the MAP and Management Review process. Lead Plant/Organizational initiatives driving business performance. Ensures compliance with Environmental Management System (EMS) responsibilities.
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:

o University/bachelor’s degree or Equivalent.
o Generally, requires (8-10) years related experience.
o Bilingual: English / Spanish, required.
o QSR, ISO and other regulatory requirements knowledge, required.
o Background in Medical Device Industry, preferred.
o Demonstrated project management skills with strong results orientation, required.

o Strong communication, influencing and presentation skills, required.
o Knowledge or completion of Process Excellence Six Sigma, Lean, and/or Design Excellence courses or a comparable process for problem solving/ decision making preferred. Green or Black Belt Certification highly desired.
o Supervisory skills, preferred.
o Experience Leading CAPAs, preferred.
o Experience with external auditing bodies, preferred.
o Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software, database management & desktop publishing.
o Networked environment experience.
 

Required Skills:

Preferred Skills: