Training Operations Manager

hace 2 semanas

Tijuana, Baja California, México Mammotome A tiempo completo
Job Summary

This role oversees the management of Training team members in an assigned region/area to ensure the successful alignment and execution of Training strategies, initiatives, and processes. The ideal candidate will be responsible for all aspects of Training including the design, coordination, and deployment of role-based training. Focus on technical training such as Training Regulatory Compliance, STPS compliance, Direct and Indirect personnel, and Professionals.

Key Responsibilities
  • Provide leadership and direction to Training team members.
  • Continually assess training strategies, programs, and metrics, implementing solutions as appropriate.
  • Oversee the design, development, and customization of training content.
  • Ensure the proper documentation of training programs.
  • Manage eTraining System (Compliance Wire), and provide indirect/direct training at specific sites to ensure compliance.
  • Monitor and respond to changes in CW data that have the potential to impact the reliability and/or automation of training assignments.
  • Training matrix design and administration across Tijuana and US.
  • Develop systems that ensure the effectiveness of training delivery and overall program effectiveness.
  • Ensure all training records are managed and stored in a timely manner according to quality management system requirements.
  • Partner with various functional groups (e.g., Manufacturing, Quality, Regulatory, Compliance, HR, etc.) to incorporate functional-based training programs into the role-based curriculums, as appropriate.
  • Assist in the establishment of training standards across the organization and develop processes and/or procedures that ensure the effectiveness of training delivery.
  • Partner with local manufacturing and quality leadership to assess training needs and determine priorities that translate into training requirements and/or programs for the teams to implement.
  • Collect and present training performance metrics to leadership during periodic meetings and forums (e.g., Quality Systems Management Review).
  • Represent Training processes during regulatory body audits/inspections and support requests for training records and/or evidence for qualification.
  • Partner with the CW Shared Services Team to support platform upgrades, and enhancements, and ensure help ticket Service Level Agreements (SLAs) are being met; identify process improvements where possible.
  • Communicate system issues affecting the business' ability to conduct and/or document training to drive awareness and timely resolution.
  • Onboarding program implementation and coordination at all levels, QSR for FDA and ISO 13485 compliance CFR21 and all applicable regulations (MDSAP/Cofepris/MDR EU).
  • Identify any annual training requirements and coordinates the execution and effectiveness of those training, such as GMPs / GDPs; ISO 13485 any other related within the applicable regulations.
  • Problem-solving, CAPAS and NC's follow up, Procedures updating, Change Control, FDA, CFR21, ISO13485 MDSAP compliance for HR and Training areas.
  • Perform additional duties and projects, as assigned.
Reporting Structure

Direct reports: Production Training Supervisor and trainers. eTraining system administrator.

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