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TELEFLEX MEDICAL INCORPORATED Sr. Quality Engineer, MDR in Maple Grove, Minnesota

Sr. Quality Engineer, MDR Date: Apr 22, 2020 Location:Maple Grove, MN, US Company: Teleflex Expected Travel: Up to 10% Requisition ID: 2207 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 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.and.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 Senior Quality Engineer is responsible for improving quality, production, and processing methods and controls in manufacturing to achieve operational excellence. This position requires the ability to build and maintain strong relationships with manufacturing engineering, material planning, and production, and to work and communicate across various levels of the organization. This position, under the direction of the Quality Engineering Manager, works closely with R.and.D, Design Assurance, Sustaining Engineering, and Manufacturing. This role will be integral in the development of EU MDR compliant devices and supporting day-to-day operations. Principal Responsibilities Determine test requirements, test methods, sample sizes and statistical analysis for qualification/verification studies for manufacturing Develop verification, validation and qualification plans and reports for manufacturing Initiate and lead non-conformance investigations regarding component failures, finished goods failures, and product returns. This includes but is not limited to performing risk analysis, determining root cause and recommending corrective action Investigate customer complaints, including product/record investigation, health risk assessments, identification of CAPA s and report generation Lead root cause analysis and CAPA closure Leads efforts to qualify specification changes and qualify new test methods Coordinate the Change Impact Assessment activities Mentor, train and provide work direction to quality engineering technicians and new quality engineers Participate in pre-design freeze quality activities Proactively eliminates possible manufacturing process defects Authors new SOPs and other documentation Demonstrates a high level of proficiency in functional area Define, plan and execute major projects related to product quality and regulatory compliance Ensure company policies and procedures are followed, taking timely corrective action with the help of HR when necessary Education / Experience Requirements BA/BS in Engineering or physical sciences required Five years of related experience