About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.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 SummaryThe Sr. QARA Analyst 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. Will also establish metrics, analyze, trend and report on employee training compliance data, labeling KPI's and document control metrics as well as support global projects impacting local operations.Principal ResponibilitiesSupport global activities related to product, including resolution of regulatory and quality issues.
Serve on Regional and Corporate level teams as assigned.
Suggest and debate alternative methods and procedures for solving problems and meeting changing related to importation, storage, distribution and commercialization.
Develop initial and subsequent modifications to the product quality maintenance to delineate areas of responsibility, personnel requirements, and operational procedures within the program.
Evaluate contents of reports from quality assurance initiatives and confers with management personnel preparatory to revisions to product assurance program.
Review procedures of departments and recommends solutions to procedure changes.
Evaluate the non-conformances, providing a treatement and solution.
Confer with representatives of material and service vendors to obtain information related to supply quality, vendor capacity to meet requirements, and vendor quality standards.
Confer 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.
Coordinate and facilitate customer, corporate compliance, and regulatory/registration audit visits.
Prepare and submit required corporate reports concerning quality reporting and general regulatory compliance.
Maintain the internal audit system.
Maintain the calibration program of all measuring and test equipment used to accept product.
Oversee and ensure 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.
Prepare and updates "fichas tecnicas" for registered products in Brazil.
Organize and administer a database of quality information required, including but not limited to product complaints, field actions, non-conformances, ship holds, and management control changes.
Develop and update 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 RequirementsEnglish proficiency is a Must - written and verbal skills.
Bachelor's degree in a science or engineering field.
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 RequirementsAdvanced Excel proficiency in Pivot tables, advanced functions, filters (Required), and Macros (Preferred)
SAP ECC Supply Chain Modules proficiency (Required)
SAP APO proficiency (Preferred)
Bilingual – English (Required) or Spanish (Preferred)
Lean and Six Sigma management methodology experience (Preferred)Travel RequiredUp to 20%Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.© 2024 Teleflex Incorporated. All rights reserved.
