Zimmer biomet is a world leader in musculoskeletal health solutions. Ourteam members are part of a company with a heritage of leadership, afocus on shaping the future, and a mission dedicated to alleviating painand improving the quality of life for people around the qa sr. Specialist is responsible for the local qms and all theactivities related to as required by the current sanitary regulations,quality controls and documents such as local procedures, workinstructions, quality holds, field actions, complaints, internal auditsin the warehouse and audits at local third parties like distributors andservice providers. This person is also responsible for local labeling,pest control and to establish storage and transport conditions for allpart numbers, and non-Conformities and capas. This position requires anadvanced understanding of medical devices and their use as well as anunderstanding of the quality and normative requirements in brazil. Principal duties and responsibilities carry out the product release after inspection to marketing in thebrazilian territory. Provide technical advice to the legalrepresentative regarding the characteristics of medical devices and therequirements of the current the stored medical devices are in the established conditions andwith the documentary support and the respective records. Guarantee themaintenance of the storage and/or conditioning areas and, in general, ofthe review and update the procedures related to the storage,conditioning, dispatch, and distribution of medical the storage and/or conditioning forms and distribution recordsare filled out at each stage of the the maintenance of the storage and/or conditioning areas and,in general, of the through monitoring and control, the traceability ofdistributed products both for the companys activities and forcompliance with the surveillance programs of the health local standard operational procedures in spanish based ongbl procedures and local legislation like handling complaints andrecalling the product from the market. As well as the follow-Up to theadverse incidents that they present and their report to the healthentity, if on local complaints, field actions and quality hold reporting tothe manufacturers in a timely zb local warehouse as well as distributors and service non-Conformities and capas as needed and proceed with root causeanalysis and investigation to close that the erp is updated for local labeling. Keep track oflocal labeling by pn and lot regulations to business practices and provides regulatory input,advice and guidance to cross-Functional responsibilities as assigned. Expected areas of competence demonstrated strong writing, communication, and interpersonal skillsstrong attention to detail ability to multi-Task and balance competing prioritiesknowledge of overall business environment, the orthopedic industry, andthe marketplaceability to learn and stay abreast of regulations pertinent to medicaldevices, biologics, drugs and combination products as needed, based onfunctional areaproficient knowledge of overall business environment, the orthopedicindustry and the marketplaceproven analytical and negotiation skillsability to building relationships between qa/ra and other areas of theorganization ability to communicate effectively at all levelsmastery of relevant regulations listed under education and experience requirementsexperience with solving problems and concerns basic computer skills,including microsoft office suite education/experience requirements bachelors require in biomedical engineer, bioengineer, physician,nurse, pharmacist, surgical proficiency is requireda minimum of one year of experience in orthopedic or medical deviceindustry preferreda minimum of 3-5 years of experience in qms travel requirements up to 35% additional information we believe in the power of us, which means that we are strongertogether. We are committed to creating an environment where every teammember feels included, respected, empowered, and celebrated. As a zimmerbiomet team member, you will share in our commitment to providingmobility and renewed life to people around the world. This is why weoffer you a competitive rewards package that includes medical, dental,meal voucher, development incentives and others.
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