Quality Assurance Specialist - Medical Devices

Position: Quality Assurance Coordinator Essential minimum 2 years’ experience in quality assurance or quality systems in production plants, distribution center and/or affiliates.

Experience in

cGMPs, cGDPs,

Quality for Marketing Affiliate. Quality Assurance and Quality control and/or manufacturing processes. Office system.

ISO 13485 for medical devices.

&##Global Responsibility Assure compliance of GxP, regulatory and internal standards according to quality policies and applicable requirements within affiliates/subsidiaries. Management of quality documentation (procedures, reports, etc.). Management of quality technical agreements and their fulfilment. Ensuring that appropriate Quality systems are established, implemented, and maintained in each market in scope, and appropriate oversight is in place to ensure that local regulatory requirements can be supported in a simple, compliance and continuous improvement manner. Providing support to Quality teams across marketing affiliates/subsidiaries per region in the resolution of serious quality issues and quality management documentation. Support Quality training program for Exeltis affiliates/subsidiaries. Third Party quality management oversight: Manage technical quality agreements between Third Partiers and Exeltis, establish a good quality management oversight in routine operations, identify risks and propose risk mitigation. Develop and monitor Quality metrics related to third party organization and marketing affiliates. Collect, prioritize, drive and monitor execution of strategic Quality initiatives in affiliates and subsidiaries. Stay current with the applicable regulations and promote Quality across the organization. Support Affiliates/Subsidiaries in the implementation of Quality digitalization strategy

&##Fluent in English, Spanish will be a plus. Essential minimum 2 years’ experience in quality assurance or quality systems in production plants, distribution center and/or affiliates Experience in cGMPs, cGDPs, Quality for Marketing Affiliate. Quality Assurance and Quality control and/or manufacturing processes. Office system.

ISO 13485 for medical devices. Permanent contract ⏰ Health insurance coverage &##Professional development opportunities