Provide guidance for auditors as necessary. Organize, plan, direct and control in an efficient manner the activities of the internal quality audit process. Propose or contribute with initiatives of continuous improvement in the internal quality audit system. Assures the implementation of new corporate requirements related to internal quality audit system. Review, examine, approve and recommend changes on local procedures and other related documents to assure compliance with corporate, regulatory and ISO 13485 requirements. Attend global conference calls and meetings related to the internal audit process. Follow up on audit responses as required. Perform quality audits to ensure compliance with regulations and ISO 13485 requirements. Manage BSC Costa Rica audit team. Could provide regulatory training (QSR, GMP, auditor training, Audit readiness among others) or support department trainers. Manage and/or support audit backroom activities during external audits. Give support to environmental or safety audits. Provide support on audit related topics to all BSC Costa Rica users. Perform administrative work for audit department in order to keep and implement BSC Costa Rica Audit Program. Give support to Supplier audits as required. Assure quality records generated from internal and external audits are kept per site requirements. Contact Global Audit and other audit departments within the corporation. Create/ generate plans and reports as required. May lead audit readiness activities. Provide support to Management Review, External Audits, CAPA/NCEPs, Quality Planning processes if required. Performance Evaluation: Successful or above. Bachelor's degree in engineering, biotechnology, microbiology or a related field. English Level desired: B2+ or above. Experience: Internal audits execution. 2+ years' experience in quality positions in the medical device industry with a solid understanding of QSR/QMSR and ISO 13485 Quality System requirements. Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio). Project/task management experience. Experience with nonconformance and/or CAPA process. Lead Auditor Certification ISO 13485 Quality System. Experience with Product Lifecycle Management systems (i.e. Windchill, PLM). Experience with AI tools (MS Copilot, ChatGPT) and/or data management dashboards (Power BI, Tableau).