Quality Manager

hace 3 semanas

Bogota, Colombia 3M A tiempo completo
3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter.

Job Description:

Quality Manager (Responsible Sanitary), Colombia at Distribution Centers

Collaborate with innovative 3Mers around the world

This position supports the entire all process related to Quality Incoming & Delivery operations, according INVIMA (National Institute for Food and Drug Surveillance) regulatory agency that regulates the medical device market in Colombia. In this role you will be able to ensure in the division of consumer health care and personal safety quality of the products that are commercialized and distributed in Colombia Distribution centers, that a Quality Management System is in place, responsible for the quality of the product, as well as deciding on the destination of returned, rejected, recalled or counterfeit products in accordance with the provisions of the Quality and Procedures Manual or in the case of outsourced services, in accordance with the provisions of the applicable legal framework, with the quality and distribution contracts, technical agreements and/or equivalent documents that apply and to apply broad knowledge and extensive experience to deal with variations in work conditions and operations to solve complex and diverse problems. Direct leadership responsibility to assigned employees with clearly defined roles. Reviews and approves work results conducted by to assigned employees.

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 

To set you up for success in this role from day one, 3M is looking for candidates who must have the following qualifications: 

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. 

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