JOB DESCRIPTION At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.Job SummaryA collaborator who is responsible for the local / regional 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 and service providers. This role is also responsible for local labeling, pest control and to establish storage and transport conditions for all part numbers, as well as expiration date control and non-conformities and CAPAs.Principal Duties and ResponsibilitiesActs as the Quality responsible, controlling daily work activities, communicating with other departments and problem solving.Establishes local standard operational procedures in Spanish based on GBL procedures and local legislation.Work on local complaints, recalls, field actions and quality hold reporting to the manufacturers in a timely manner.Act as postmarket (Technovigilance) Responsible.Assess and conduct local complaint reportability.Prepares and submit periodic safety reports.Conduct local training to the personnel.Perform finished goods labeling and shipment inspection of catalog items distributed.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 systems are updated for local labeling.Keep track of local labeling by PN and lot number.Establishes and updates local risk management.Schedules QMS management review with stakeholders and the general manager twice a year.Assist various departments with document retrieval as needed.Generates reports, analyzes tends and performs other duties, as needed.Support to QA/RA Manager responsible with audits from government (Ministry of Health, CCSS)Education/Experience RequirementsBachelor's degree: Chemical, Pharmaceutical, Industry, Engineer. Alternate degrees may be consideredRegistered in the local professional entity. English Proficiency is required.3-5 years of experience in orthopedic or medical device industry preferred3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field requiredInternational standards such as: ISO 13485, ISO 9001, Local standards, Decree No 34482-S, Decree 41387-S and applicable standards for medical device distribution warehouses.Technovigilance experience.Travel Requirements5%EOE/M/F/Vet/Disability
