Manager Quality Assurance

JOB Purpose of the main job Responsible for administering and supervising the Quality Management System of the LATAM region (Mexico, Brazil, Chile, Argentina), as well as keeping updated the health records of medical devices corresponding to Perkin Elmer Diagnostics products in Mexico. This person is responsible for the coordination, as well as the effectiveness, strategy, and general sustainability of the LATAM Quality Management System, in line with the resources available in each area of the company. This person is also responsible for technical management over medical devices with the Mexican authorities (Cofepris) to allow the sale of Perkin Elmer Diagnostics products in Mexico, working alongside the regulatory team. This position reports to the Director of Global Service Quality. Main responsibilities Develop, manage and maintain the quality management system necessary to successfully support Perkin Elmer products distributed in LATAM. Technical responsible manager over medical devices and equipment introduced to and distributed in Mexico. Interact with other functional groups (service, customer service, sales, manufacturing, warehouse and others as necessary) to implement and maintain the LATAM Quality Management System, include Standard Operating Procedures, follow up on systems and databases data always in line with the realities, needs and resources of each group. Implement and monitor the completion of recalls. Initiate, support investigation, reporting and closure of complaints. Initiate, support investigation and closure of deviations / non-conformities. Initiate, support the investigation and closure of corrective / preventive action projects (CAPAs). Perform internal audits and manage the internal audit program. Initiate and maintain quality metrics for monthly operational reviews locally and quarterly at the corporate Diagnostic Meeting (QMR). Communicate to appropriate personnel the quality system requirements for medical devices in LATAM. Assist LATAM Regulatory team when necessary for the registration, including extensions, modifications, and technovigilance reports, of products before the health authorities of Mexico. Work with Quality Systems team in support of LATAM Learning Management System (LMS) administration of training on specific business requirements as well as SOPs and Work Instructions in accordance with company-wide job descriptions. Provide quality supervision in inventory control of medical devices distributed in LATAM. When necessary, develop, manage and communicate quality plans and objectives for projects to ensure their completion. Other operations that are considered necessary and assigned by the administration. Training to be received as part of the induction SAP, quality modules LMS Code of Ethics Global Bribery and Corruption Awareness Quality Awareness Personnel overseen None REQUIRED COMPETENCE Education Desirable bachelor's degree in Science or a related area (eg QFB, Pharmaceutical Engineer, etc.), preferably postgraduate studies (eg Master of Administration, Pharmacy, etc.). Required work experience related to position 3 to 5 years in similar positions, 10 years of experience in quality assurance (ISO : , NMX-EC IMNC , NOM-241-SSA , NOM-240) as applied in the pharmaceutical and medical device industry. Experience to evaluate adverse incidents. Special requirements (courses, diplomas, etc.) Sanitary regulation in medical devices Good manufacturing practices Diploma in quality ISO ISO Risk analysis English, Spanish language required. Portuguese language in addition perferred. Management by results Emotional intelligence Assertive management style in conflict situations Travel across LATAM : 10% #J-18808-Ljbffr