QARA Specialist

Position Summary

The QARA Specialist will support Quality System and Regulatory Affairs elements for Teleflex Logistics and Distribution centers within Brazil that support Technovigilance, Regulatory actions, Labeling, Document Control and Quality Systems Training in accordance with internal procedures and external regulations and standards. Establish metrics, analyze, trend and report on employee training compliance data, labeling KPI’s and document control metrics as established. Support global 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 related to importation, storage, distribution and commercialization.
• 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.
• Review 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 responsibility before ANVISA.
• Vigilance contact before ANVISA regarding field actions and product complaints.
• Manage the labeling database for Brazil nationalization labels.
• Prepares and updates “fichas tecnicas” for registered products in Brazil.
• 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 Brazil.
• Ensure 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 and nationalization labelling.
• Maintain the quality system (documents and activities) and constantly improve the process involved.
• Liaison between the warehouse and Teleflex Brazil about ship holds, including restrictions and disposition of local products.
• Communicate 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.
• Manage the GMP certificates related to manufacturing and perform the necessary interfaces.
• Submit to ANVISA the technical documentation required to maintain the product licenses updated and available to import.
• Support 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)
• Familiar with ANVISA, FDA, cGMP, and ISO quality system requirements for a diverse medical device manufacturer.

Specialized Skills / Other Requirements

• SAP ECC Supply Chain Modules proficiency (Required)
• SAP APO proficiency (Preferred)
• Bilingual – English (Required) or Spanish (Preferred)
• MS Office Suite
• Advanced Excel proficiency in Pivot tables, advanced functions, filters (Required), and Macros (Preferred)
• Lean and Six Sigma management methodology experience (Preferred)