This job has expired.
Expected Travel: Up to 10%
Requisition ID: 6637
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.
Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary
The Configuration Management Associate is responsible for performing tasks that drive the timely release and change of product documentation and supporting data throughout the lifecycle of products and ensuring conformance to applicable MDR, QS and other applicable requirements. This position will evaluate and process electronic change orders for completeness and adherence to procedures and will ensure appropriate distribution and notification.
Principal Responsibilities
• Subject matter expert in change control as it relates to product lifecycle
• Facilitate the timely change, approval, and release of product documentation and data (PLM, ERP)
• Maintain new Item Master set-up and other related data in applicable ERP
• Prepare Quality records for electronic scanning and off-site archiving; administer the system for archiving and off-site storage of document control and data records in accordance with defined requirements
• Generate, assign, update, and ensure accuracy of the Global Trade Identification Number (GTIN) information in the Data Sync Direct
• Partner with Regulatory and Packaging/Labeling teams to oversee and manage IFU-to-Web process and ensuring MDR regulatory requirements are met and maintained
• Support development of new product documentation and provide detailed reports, queries or summaries in support of various cross-functional projects and initiatives
• Provide inventory control and maintenance of the central document reference library, including standards and guidelines
• Assist in monitoring process effectiveness, including the impact of changes, and recommend process improvements
• Utilize visual management and participate in problem solving, metric reporting/improvement, and other various projects, as assigned
• Apply best practices in change control, configuration management, and continuous improvements
• Provide high-level customer service and support to specific cross-functional areas
• Participate in and/or lead special projects, as assigned
• Provide audit and training support, as requested
Education / Experience Requirements
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