Quality Sr. Specialist

**Requisition Number**: AMER28364

**Employment Type**: Full-time

**Location**: Sao Paulo

**Job Summary**: Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

The QA Sr. Specialist is responsible for the local QMS and all the activities related to as required by the current sanitary regulations, 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 and service providers. This person is also responsible for local labeling, pest control and to establish storage and transport conditions for all part numbers, and non-conformities and CAPAs. This position requires an advanced understanding of medical devices and their use as well as an understanding of the quality and normative requirements in Brazil.

**Principal Duties and Responsibilities**: Carry out the product release after inspection to marketing in the Brazilian 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 warehouse.
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.

**Expected Areas of Competence**: 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

**Education/Experience Requirements**: Bachelor’s require in Biomedical engineer, bioengineer, physician, nurse, pharmacist, surgical instrumentation.
English Proficiency is required
A minimum of one year of experience in orthopedic or medical device industry preferred
A 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 stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, meal voucher, development incentives and others.