3MQuality Manager (Responsible Sanitary), San Luis Potosí
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Job Description:
Collaborate with innovative 3Mers around the world
As Quality Manager and Responsible Sanitary you will play a key role for Quality Management system (QMS) main role responsibility according to Official Mexican Technical Regulation NOM-241-SSA1-2021, Good manufacturing practices for medical devices (GMP), in the division of consumer health care and personal safety quality of the products that are commercialized and distributed in Mexico Distribution center. In this role you will be able to ensure 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
Quality Management System (QMS) maintenance of medical devices.
Management Review and Risk management
On-hold inventory Oversight and Recall process
Corrective Action Preventive Actions (CAPA) Oversight
Techno-surveillance
Supplier quality support, together with LATAM Supplier Quality Management (SQM)
Validations & qualifications, Control of changes
PLM administration
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:
Bachelor's degree in the pharmaceutical, chemical, biological, medicine, biomedical, biochemistry or other profession, as long as it is related to the process.
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).
Have proven experience in a quality assurance control position. 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.
English as second language proficiency.
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.
Work Location: This role follows an on-site working model, requiring the employee to work at the 3M Distribution Center in San Luis Potosí.
Travel: May include up to 5%
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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