Knowledge of regulatory standards (ISO 13485; ANVISA RDC 665/22) and product development (design and validation checks) Fluency in English and Portuguese is required Knowledge of the advanced Office package Knowledge of and experience with QMS in the medical industry (standard implants, plates, and screws) Experience with internal and external audits (ISO 13485; ANVISA RDC 665/22) and CAPA Mechanical engineering degree or similar Ability to deal with and understand technical difficulties related to the areas of expertise Ability to work collaboratively with other technical departments to proactively and pragmatically bring solutions within regulatory standards Ability to monitor the QMS through effective reports to senior management Ability to represent the company in audits Critical and analytical mindset Flexibility Problem-solving ability by identifying the root cause and proposing appropriate actions Manage the activities of the quality management system (QMS) department Develop and maintain the QMS under regulatory standards and requirements. Review quality management, reporting actions to top management Participate in internal and external audits (ISO 13485; ANVISA RDC 665/22; customers; EU NB) Manage CAPA system Be responsible for the go/no go gating of products and processes (working directly with the research & development and process engineering departments) Work on developing the product, ensuring that the decision-making is aligned with the requirements of the QMS Change the production process as necessary, ensuring that decision-making is aligned with the requirements of the QMS Responsible for the Historical Record of the product Complaint documentation