Sr. QARA Specialist

Sr. QARA Specialist Position Summary Supports Quality Assurance and Regulatory Affairs elements for Teleflex Logistics and Distribution Center within Argentina. Main activities include serving as the Technical Director to provide support on Technovigilance, local labeling processes, document control; delivering 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 Supports global activities related to product, including resolution of regulatory and quality issues. Serves on Regional and Corporate level teams as assigned. Suggests and debates alternative methods and procedures for solving problems and meeting changing requirements related to importation, storage, distribution and commercialization. Ensures that product is stored according to correct storage conditions. Develops 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 prior to revisions to the product assurance program. Reviews procedures of departments and recommends solutions to procedure changes. Evaluates non-conformances, providing treatment and solution. Confers with representatives of material and service vendors to obtain information related to supply quality, vendor capacity to meet requirements, and vendor quality standards. Confers with Teleflex Manufacturing sites about quality assurance aspects of manufactured products. Reviews technical publications, articles, abstracts, and standards to stay abreast of developments in the industry. Coordinates and facilitates customer, corporate compliance, and regulatory/registration audit visits. Prepares and submits required corporate reports concerning quality reporting and general regulatory compliance. Maintains the internal audit system. Maintains the calibration program of all measuring and test equipment used to accept product. Oversees and ensures the documentation system is adequate for assigned sites. Technical Director before ANMAT. Vigilance contact before ANMAT regarding field actions and product complaints. Manages the labeling database for Argentina nationalization labels. Prepares and updates technical datasheets for registered products in Argentina. Organizes and administers a database of quality information required, including product complaints, field actions, non-conformances, ship holds, and management control changes. Develops and updates procedures for Teleflex Argentina as necessary. Ensures regulations required for commercialization are met, such as testing procedures of medical equipment after importation and before commercialization, applicable seals, patient traceability labels, and nationalization labeling among others. Maintains the quality system (documents and activities) and continuously improves the involved processes. Liaison between the warehouse and Teleflex Argentina about ship holds, including restrictions and disposition of products locally. Communicates any potential or significant quality issues caused or received by the warehouse, such as water damage, warehouse control failures in temperature, humidity, pest control, or cleaning. Manages the GMP certificates, when applicable, related to manufacturing and performs the necessary interfaces. Submits to ANMAT the technical documentation required to maintain the product licenses updated and available to import. Supports the importation process. Education / Experience Requirements BS or BA degree in Engineering, Science, or a related field; preferred pharmaceutical. Minimum of 7 years of professional experience in coordinating logistics, warehousing, customs, and transportation processes (preferably with a medical device manufacturer or large manufacturing-based organization). Complete knowledge of ANMAT, FDA, cGMP, and ISO quality system requirements for a diverse medical device manufacturer. ISO 13485 and ISO 9001 audit certification preferred but not required. Specialized Skills / Other Requirements SAP ECC Supply Chain Modules proficiency (Required). SAP APO proficiency (Preferred). Bilingual – English (Required). MS Office Suite Advanced Excel proficiency in Pivot tables, advanced functions, filters (Required), and Macros (Preferred). Lean and Six Sigma management methodology experience (Preferred). At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2025 Teleflex Incorporated. All rights reserved. #J-18808-Ljbffr