Sr. QAra Specialist

Date : Jul 25, 2025 Location : Buenos Aires, B, AR Company : Teleflex About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.Latin America - The Latin America Region of Teleflex is headquartered in Morrisville, North Carolina, and supports our customers, distributors, sales managers and specialists in Mexico, Brazil, Colombia, Chile, Argentina and Puerto Rico. The Latin America Region sells a broad spectrum of medical devices and related products in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. As Teleflex grows and expands its portfolio, we will continue to grow our presence in Latin America. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. Position Summary Supports Quality Assurance and Regulatory Affairs elements for Teleflex Logistics and Distribution Center within Argentina. Main activities include being the Technical Director to provide support on Technovigilance, local labeling processes, document control; quality systems training in accordance with internal procedures, external regulations, and international standards. Establishes metrics, analyzes trends and reports on employee training compliance data. On the Regulatory side, the Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. Where applicable, this position will assist in mentoring and development of staff members as part of the role- The Sr. RAQA Specialist supports global quality and regulatory projects impacting local operations. Principal Responsibilities Quality Assurance function through the following activities, but not limited toSupports global activities related to product, including resolution of regulatory and quality issuesServes on Regional and Corporate level teams as assignedSuggests and debates alternative methods and procedures for solving problems and meeting changing related to importation, storage, distribution and commercializationEnsures that product is stored according to correct storage conditionsDevelops initial and subsequent modifications to the product quality maintenance to delineate areas of responsibility, personnel requirements, and operational procedures within the program Evaluates contents of reports from quality assurance initiatives and confers with management personnel preparatory to revisions to product assurance programReviews procedures of departments and recommends solutions to procedure changes.Evaluates the non-conformances, providing a treatment and solutionConfers with representatives of material and service vendors to obtain information related to supply quality, vendor capacity to meet requirements, and vendor quality standardsConfers with Teleflex Manufacturing sites about quality assurance aspects of manufactured productsReviews technical publications, articles, abstracts, and standards to stay abreast of developments in the industry Coordinates and facilitates customer, corporate compliance, and regulatory/registration audit visitsPrepares and submits required corporate reports concerning quality reporting and general regulatory complianceMaintains the internal audit systemMaintains the calibration program of all measuring and test equipment used to accept productOversees and ensures the documentation system is adequate for assigned sites Technical Director before ANMATVigilance contact before ANMAT regarding field actions and product complaintsManages the labeling database for Argentina nationalization labelsPrepares and updates “technical datasheets” for registered products in ArgentinaOrganizes and administers a database of quality information required, including but not limited to product complaints, field actions, non-conformances, ship holds, and management control changesDevelops and updates as necessary, the procedures for Teleflex Argentina Ensures that regulations required for commercialization are met, such as but not limited to the testing procedures of medical equipment after importation and before commercialization, applicable seals, patient traceability labels, and nationalization labeling among othersMaintains the quality system (documents and activities) and constantly improves the process involved Hubspot Admin / Sr Marketing Operations Specialist PerconaAre you a Senior Marketing Operations Specialist looking for a high-growth tech company that offers a global, remote-only environment and a great culture? 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