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Change Management Specialist
hace 2 meses
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 changes are properly documented and implemented.
- Coordinate and lead the efforts to guarantee that procedures, work instructions, and templates used in Plant operations are aligned to Corporate's.
- Manage the activities of personnel under your supervision to achieve individual and Quality System objectives.
- Create and monitor 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 required training.
- Review the "Issued Specification Report" daily to detect revision changes and distribute revised documents among appropriate personnel.
- 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 performed in Plant Operations and provide information for QSRB or Management Review meetings in a timely manner.
- Serve as Internal auditor in the audit process when required and provide training in the Agile system for change process when required.
- Advanced English proficiency.
- Valid VISA.
- Bachelor's degree in Industrial Engineering, Chemistry, Quality, or similar field.
- 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.
- High degree of initiative and good judgment.
- Knowledgeable in using Agile PLM Import Tool and competent in Agile searches.
