QA Senior Specialist

**Requisition Number**: AMER26956

**Employment Type**: Full-time

**Location**: Santiago

**Descripción del Trabajo**: A collaborator who is responsible for the local QMS and all the activities related to quality controls and documents such as local procedures, work instructions, quality holds, field actions, complaints, internal audits in the warehouse and audits at local third parties like distributors, consignment locations and service providers, as required by the current sanitary regulations. This person is also responsible for local labeling, pest control and to establish storage and transport conditions for all part numbers, as well as non-conformities and CAPAs.
This position requires an advanced understanding of medical devices, their use and understanding of the quality and normative requirements in Chile.

**Deberes y responsabilidades principales**: -. - Carry out the product release after inspection to marketing in the Chilean territory. - Provide technical advice to the legal representative regarding the characteristics of medical devices and the requirements of the current regulations. - Ensure the stored medical devices are in the established conditions and with the documentary support and the respective records. Guarantee the maintenance of the storage and/or conditioning areas and, in general, of the facilities of the logistics operators (2) - Permanently review and update the procedures related to the storage, conditioning, dispatch, and distribution of medical devices. - Verify the storage and/or conditioning forms and distribution records are filled out at each stage of the process. - Guarantee the maintenance of the storage and/or conditioning areas and, in general, of the facilities. - Guarantee, through monitoring and control, the traceability of distributed products both for the company's activities and for compliance with the surveillance programs of the health authorities. - Establishes local standard operational procedures in Spanish based on GBL procedures and local legislation like handling complaints and recalling the product from the market. As well as the follow-up to the adverse incidents that they present and their report to the health entity, if applicable. - Work on local complaints, field actions and quality hold reporting to the manufacturers in a timely manner. - Audits ZB local warehouse as well as distributors and service providers. - Opens non-conformities and CAPAs as needed and proceed with root cause analysis and investigation to close them. - Guarantee that the ERP is updated for local labeling. Keep track of local labeling by PN and lot number. - Applies regulations to business practices and provides regulatory input, advice and guidance to cross-functional teams - Other responsibilities as assigned

**Áreas de competencia previstos**: - Demonstrated strong writing, communication, and interpersonal skills - Strong attention to detail; ability to multi-task and balance competing priorities - Knowledge of overall business environment, the orthopedic industry, and the marketplace - Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area - Proficient knowledge of overall business environment, the orthopedic industry and the marketplace - Proven analytical and negotiation skills - Ability to building relationships between QA/RA and other areas of the organization; ability to communicate effectively at all levels - Mastery of relevant regulations listed under education and experience requirements - Experience with solving problems and concerns Basic computer skills, including Microsoft Office Suite

**Requisitos de Educación / Experiência**: - Bachelor’s degree (or non-US equivalent) required. - Degree in: Biomedical engineer, bioengineer,, physician, nurse, pharmacist, surgical instrumentation. - Advanced degree preferred - English Proficiency is required - A minimum of two years of experience in orthopedic or medical device industry preferred - A minimum of 5-10 years of experience in, QMS, International standards such as: ISO 13485, ISO 9001, ISO 14975, ICH, and MDR, Local standards such as: Decree 825/1998, Technical General Norm #204, and its modifications. - A combination of education, experience, leadership, strategy, and QA/RA influence may be considered Quality and RA experience

**Requisitos de Viaje**: Minimal, up to 10%.