Technical Responsible Officer

Description

Job Summary: Nurse with an active COREN registration for regulatory documentation management, compliance supervision, and implant inventory management. Key Highlights: 1. Regulatory certificate and license management and renewal. 2. Supervision of compliance with RDC No. 16/2013 regarding inventory and operations. 3. Implant inventory management and traceability, including NCRs. Required Qualification: Completed Nursing degree with active COREN registration. Responsibilities: \- Requesting, tracking, and renewing all company certificates related to licenses, declarations, and certificates, including Operating License (AFE), Sanitary Surveillance License, Fire Department Certificate, Environmental License, Municipal License, and others; \- Updating municipal, state, federal, and union tax debt certificates; labor debt certificates; FGTS statements; declaration of employment of minors under 18 years old; SINTEGRA; and CNPJ card; \- Monitoring, supervising, and guiding warehouse staff and other company employees regarding compliance with RDC No. 16/2013 (warehouse cleaning, temperature control, goods receipt, proper storage and distribution of materials); \- Monitoring and requesting periodic pest control services every three months, as well as scheduling water tank cleaning every six months, preferably on Saturdays; \- Monitoring air conditioning maintenance and scheduling maintenance appointments; \- Monitoring fire extinguisher validity and replacement, as well as inspecting emergency lighting and guidance signage per Fire Department requirements; \- Managing implant inventory, including expired items, items nearing expiration, quarantined items, non-conformance records, and organization; \- Supervising and managing implant expiration dates. Generating reports on items nearing expiration and segregating them on shelves labeled “MATERIALS NEARING EXPIRATION”; \- Receiving cleaned, sharp, and contaminated materials; storing them; preparing disposal requests; and issuing invoices for expired and damaged materials; \- Requesting waste collection from qualified service providers; \- Monitoring and segregating implant batches subject to RECALL/QUARANTINE notices issued by ANVISA or manufacturers, and storing them in designated cabinets; \- Monitoring and requesting Non-Conformance Reports (NCRs) when implant-related issues are identified; \- Tracking NCRs related to implants—from identification in the operating room, through industry notification, form completion, issuance of warranty exchange invoices, to forwarding implants for analysis; \- Preparing packaging for shipment via the postal service portal; \- Monitoring NCR analysis by manufacturers and returning results to relevant parties; \- Supplier qualification and updating documentation with companies/manufacturers; \- Maintaining distribution and commercialization letters for partner companies; \- Maintaining, monitoring, and updating documentation on the GMS platform—the State of Paraná’s Procurement Portal; \- Ensuring implant traceability per manufacturer requirements; \- Monitoring and updating documentation for contracts with manufacturers, particularly technical documentation and quality agreements; \- Actively participating in bidding processes, meetings, and submission of all required technical and legal company documentation; as well as participating in bid proceedings on the scheduled date, regardless of time; \- Organizing and maintaining documentation for external audits, when requested by entities such as UNIMED, Sanitary Surveillance, and ZIMMER; \- Developing and delivering training to company staff on quality-related topics: operational protocols and other necessary technical training; \- Developing and updating operational protocols; \- Issuing authorization letters for merchandise transportation to logistics providers; \- Monitoring and requesting occupational health examinations for staff via the Medwork online system and archiving ASOs; \- Monitoring and ensuring the registration and regularity of all surgical technologists; \- Liaising with regulatory agencies such as Sanitary Surveillance and COREN; \- Archiving and organizing all company documentation. Compensation: Gross Salary: R$ 2\.375,00 Benefits: \- Hazard Pay: 20% \- Meal Allowance: R$ 250,00 (R$40,00 deducted from payroll) \- Transportation Allowance (for public transport) \- Gym membership via Gympass/Wellhub \- Health insurance after probation period \- Dental insurance after probation period \- Life insurance after probation period Job Type: Part-time, Permanent CLT Payment: R$2\.375,00 per month Benefits: * Medical assistance * Dental assistance * Life insurance * Meal allowance * Transportation allowance Work Location: On-site