Quality Manager
hace 1 semana
**Job Description**:
Quality Manager (Responsible Sanitary), Colombia at Distribution Centers
Collaborate with innovative 3Mers around the world
The impact you will make in this role
- 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
Your Skills and Expertise
- 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.
Additional qualifications that could help you succeed even further in this role include:
- 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
Supporting Your Well-being
3M offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.
Imagine your future in 3M
3M es un empleador que ofrece las mismas oportunidades. 3M no discriminará a ningún solicitante de empleo por razones de raza, color, edad, religión, sexo, orientación sexual, identidad o expresión de género, origen nacional, discapacidad o estado de veterano.
Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M’s business and performance goals. You have flexibility in where and when work gets done. It all depends on where and when you can do your best work.
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