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Change Management Specialist

hace 2 meses


Tecate, Baja California, México Teleflex A tiempo completo
Job Summary

We are seeking a highly skilled Change Management Specialist to join our team at Teleflex. As a key member of our Quality Assurance department, you will be responsible for coordinating and leading document control and quality system records, as well as managing the process of controlling changes in the Quality System.

Key Responsibilities
  • Coordinate and lead document control and quality system records to ensure accuracy and compliance.
  • Manage the process of controlling changes in the Quality System, ensuring that all personnel are aware of and comply with changes.
  • Develop and implement a development plan for personnel under your supervision to ensure they are prepared and qualified to meet their responsibilities.
  • Guarantee that personnel under your supervision comply with safety regulations and procedures.
  • Review the "Issued Specification Report" daily to detect revision changes and distribute revised documents as necessary.
  • Maintain a record of document controlled copies distributed in the Plant and an inventory of controlled copies of external documents.
  • Monitor and comply with safety procedures and politics.
  • Provide support during audits and provide information for QSRB or Management Review meetings as required.
  • Serve as Internal auditor in the audit process when required.
Requirements
  • Advanced English language skills.
  • Valid VISA.
  • Bachelor's degree in Industrial Engineering, Chemistry, Quality, or similar field.
  • 2+ years of experience in medical device/pharmaceutical/biotech configuration assurance or related field.
  • Familiarity with modern ERP systems, PLM systems, and/or manufacturing documentation.
  • Proficient in Microsoft Office and Agile, SAP, and Winshuttle software systems.
  • Excellent analytical, verbal communication, and writing skills.
  • Ability to work in a team environment and independently with minimal supervision.
Working Conditions

This is a full-time position with a regular working schedule from Monday to Friday, 7:00 a.m. to 5:30 p.m.