Senior Quality Assurance and Regulatory Affairs Analyst

3 semanas atrás

São Paulo, São Paulo, Brasil Teleflex Tempo inteiro
About Teleflex

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. 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.

Job Summary

The Senior Quality Assurance and Regulatory Affairs Analyst will support Quality System and Regulatory Affairs elements for Teleflex Logistics and Distribution centers within Brazil. This role will be responsible for ensuring compliance with internal procedures and external regulations and standards.

Key Responsibilities
  • Support 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 confer with management personnel preparatory to revisions to product assurance program.
  • Review procedures of departments and recommend solutions to procedure changes.
  • Evaluate non-conformances, providing a treatment 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 standards 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 update "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 labeling.
  • 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.
Requirements
  • English 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
  • Advanced 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 Required
  • Up to 20%.

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