Quality Assurance Specialist

Position Summary

The Quality Assurance Specialist will support Quality System elements for Teleflex Logistics and Distribution centers within Colombia that support Labeling, Document Control and Quality Systems Training in accordance with internal procedures and external regulations and standards. Also will establish metrics, analyze, trend and report on employee training compliance data, labeling KPI’s and document control metrics, as well as give support for global projects impacting operations within L&D.

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 in solving problems and meeting changing related to importation, storage, distribution and commercialization.
• Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements, and operational procedures within 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 problems or changes in procedures.
• Confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards.
• Confers with Teleflex Manufacturing sites about quality assurance aspects of manufactured products.
• Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.
• Coordinates and facilitates customer, corporate compliance, and regulatory/registration audit visits.
• Prepares and submits required corporate reports relative to 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 in place and effective for assigned sites.
• Provides support to the evaluation and quoting of new business opportunities via project and specification review, project and costing analysis and associated negotiations with new and existing customers.
• Technical Responsible before INVIMA.
• Vigilance contact before INVIMA regarding field actions and product complaints.
• Manage the labeling database for nationalization labels.
• Prepares and updates “fichas tecnicas” for registered products in Colombia.
• 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 updates as necessary, the procedures for Teleflex Medical Colombia SAS.
• Ensure that regulations required for commercialization are met, such as but not limited to reviwing procedures of medical equipment after importation and prior to commercialization, and nationalization labelling. 
• Maintain the quality system (documents and activities) and constantly improve the process involved
• Liaison between the warehouse and Teleflex Medical Colombia SAS in relation to ship holds including restriction and disposition of local product.
• Communicate any significant or potential significant quality issues caused or received by the warehouse such as but not limited to water damage, warehouse control failures in temperature, humidity, pest control, or cleaning
• Support the importation process.

Education / Experience Requirements

• English proficiency is a must (B2 level and above)
• Experience in the medical device industry is a mandatory requirement.
• BS or BA degree in Engineering, Science or a related field; preferred pharmaceutical chemistry.
• A minimum of 3 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 INVIMA, FDA, cGMP, and ISO quality system requirements for a diverse medical device manufacturer.

Specialized Skills / Other Requirements

• SAP ECC Supply Chain Modules proficiency
• SAP APO proficiency
• Advanced Excel proficiency - Pivot tables, advance funtions, filters (Required), Macros (Preferred)
• Lean and Six Sigma management methodology experience