Sr. QARA Specialist

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 Responsabilities

Quality Assurance function through the following activities, but not limited to
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 related to importation, storage, distribution and commercialization
Ensures that product is store 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 preparatory to revisions to product assurance program
Reviews procedures of departments and recommends solutions to procedure changes.
Evaluates the non-conformances, providing a treatement 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 standars 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 but not limited to product complaints, field actions, non-conformances, ship holds, and management control changes
Develops 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 trazability labels, and nationalization labelling among others
Maintains the quality system (documents and activities) and constantly improve the process involved
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 at the warehouse, such as but not limited to water damage, warehouse control failures in temperature, humidity, pest control, or cleaning
Manages the GMP certificates, when applicable, related to manufacturing and perform 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
• A 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 with ANMAT, FDA, cGMP, and ISO quality system requirements for a diverse medical device manufacturer.
• ISO 13485 ISO 9001 audit certified 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.

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