At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.
Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
We are in this for life.
We are changing the trajectory of human health, YOU CAN TOO.
Please visit https://www.jnjmedicaldevices.com/es-419 for more information.
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EXPERIENCE AND EDUCATION

• Technical or Truncated career (2+ years)
• 4 to 7 years of experience in training, preferably
• Experience working with the FDA and/or European regulatory environment (preferably).
• Truncated Career
• Concluded Bachelor in Science, Engineering or Education (Preferably)
• Experience working with regulations and standards applicable to the medical and health industry.
• Quality Control position in which he/she has performed audits, designed SOP (Operation Procedures) and good knowledge of GXPs.
• Experience supervising projects or coordinating functions related to training.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Ability to communicate in English, orally and in writing.
• GMP/ISO knowledge.
• Knowledge in cross training planning.
• Knowledge of Training Systems (preferably).
• Presentation skills.
• Requirements of Ministry of Labor and Social Prevention.
• Use of computer systems.
• Communication skills.
• Experience in FDA/European Regulatory environments
• Strong knowledge of regulations and standards applicable to the medical and health industry.
• Expert in Training Systems.
• Leadership and coaching skills are required.
• Project management skills.
• Experience working with Manufacturing, Operations, New Products and R&D.
• Capacity to manage complex calendars and projects/assignments.
• Translator Certification (preferably).
• TWI Certification (Training Within an Industry), preferably.
• Yellow and Orange belt certification (preferably).

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

• Coordinates and conducts the training process for new recruits.
• Manages and provides maintenance to the Curricula and Training Records.
• Manages and provides maintenance to the training electronic system.
• Provides support to the organization in the preparation of curricula of functional trainings in operations for the areas of New Products or production lines.
• Coordinates and conducts training in regulative and operational modules for all the personnel if required.
• Manages and monitors the compliance of training for Contractors.
• Coordinates and prepares information in regards to the training for external, Mexican, legal agencies/entities.
• Provides support based on the training area during audits/inspections.
• Prepares training Reports for the Metrics report system.
• Coordinates and provides maintenance to resources of the training area (equipment and material).
• Provides training programs as required.
• Communicates any situation related to the company to the next managerial level.
• Provides the training systems to the company in order to comply with the statutes of health, safety and environment establish by the federal, state and local laws.
• Performs any other task as required.
• Manages department expenses and generates purchase orders.

If the OpCert applies for the company:
o Creates and modifies training material related to the OpCert program according to the production needs of each company in the plans and multiple companies if required.
o Provides and coordinates certification training for Quality Assurance technicians and operators (presentations, manuals, materials, rooms, etc.).
o Coordinates the OpCert certification for the chosen candidates in the different manufacturing areas of Salvarcar plant.
o Ensures that all the activities are properly documented according to the OpCert Certification Program, keeping an adequate record available for audits.
o Creates, revises and approves the exams for certification in Compliance Wire, according to the certification process of the operator for each company.
o Coordinates with Quality Assurance and Manufacturing the implementation activities to certify/audit associates in a specific work function.
o Changes the certification status in the Compliance Wire system when applicable.
o Revises the training records of associates in order to begin the certification process.
o Files the documentation related to the program such as: certification requisition forms, practice evaluation forms, monthly audit form, curriculum removal requisition forms during a year. Removes this function of the system if applicable.
o Provides OpCert reports metrics and/or information to business unit, when required.
o Provides support in audits when required to provide information related to the program.
o Enters trainings related to the program in the Compliance Wires system, in order to complete the certification in the system.
o Coordinates projects or activities that execute the Training Coordinators I and II as well as the Trainers. (Orientation programs, ME2, operator certification, cross training, TWI (Training Within an Industry), internal and external audits.
o Expert in the organization in the administration process. Training curricula and records.
o Expert in the training electronic system. Acts as a principal trainer in the training electronic system to all the functions of the organization.
o As a Certified Trainer, provides trainings in their specialty areas.
o Guides the organization in the preparation of curricula of functional trainings in operations for the area of New Products or production lines.
o Leads the rest of the coordinators in the preparation of training information for the external, Mexican, legal agencies/entities.
o Provides support as an expert of the training electronic system, training curricula administration and records during audits and inspections.
o Can create procedures and/or collaborate in regards of the training processes (administration of training curricula, training records TWI (Training Within an Industry), OP Cert, file, regulatory external agencies, operator certification, audit processes, etc.).
o Communicates any situation related to the company to the next managerial level.
o Evaluates the needs of the plant and performs a task analysis as support to the development of training programs, technical areas, systems, etc.
o Representative in the training department in company programs and can act as a representative before internal and external auditors. 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