Quality Manager (Responsible Sanitary), Colombia at Distribution Centers
3M
- Bogotá DC
- Permanente
- Tiempo completo
- Implementation guide of storage capacity requirements and conditioning for importers of medical devices and biomedical equipment.
- Ensuring compliance with good manufacturing practices (GMP) and standard operating procedures; ensuring that activities do not exceed the limits set by the authorization and do not differ from those activities which are authorized; and ensuring the performance of validation analysis of the distribution processes and systems involved.
- Quality Management System (QMS) maintenance of Medical devices.
- Coercitive Action Preventive Actions (CAPA) Oversight
- Supplier quality support, together with LATAM Supplier Quality Management (SQM)
- Internal audits & auto inspections
- Title and professional license issued and registered by the competent educational authorities or equivalent document in the case of foreigners, recognized by the competent educational authorities; as well as knowledge and experience demonstrable through the curriculum vitae, according to the process, which allows decision making in aspects of Goods Manufacturing Practice or Buenas Practicas de Almacenamiento y Distribution (BPAD)
- Minimum of 5 years of experience in the position of Responsible Sanitary for medical devices.
- Advanced knowledge in quality management systems and post-marketing product surveillance activities.
- Fluency in English
- Expert/master knowledge and experience with the most current theories and practices of one or more related disciplines such as quality assurance, product quality control, in-coming quality control, calibration.
- Provides direct supervision to assigned employees through leadership, coaching, training, development, allocating work assignment, review of progress in achieving objectives.
- Ensure, through monitoring and control, the traceability of the medical devices distributed both for the company's own activities and for compliance with the medical device surveillance programs corresponding to the health authorities.
- Take responsibility for complaint handling and medical device recall procedures. As well as the monitoring of adverse incidents that occur and their reporting to the health entity.
- To Provide technical advice to the legal representative regarding the characteristics of the medical devices, as well as meeting the requirements of current regulations