Quality Engineer III, Design Assurance **Date:** Oct 11, 2024 **Location:** Maple Grove, MN, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** :11148 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit **teleflex.com** . **Global Operations -** Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. **Position Summary** As a member of a cross-functional team, the Quality Engineer III, Design Assurance is responsible for quality throughout design transfer and commercialization and sustaining projects. The Quality Engineer III, Design Assurance ensures that applicable elements of the Quality System and external standards are followed. As the voice of Quality, the Quality Engineer III, Design Assurance applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization. **Principal Responsibilities** • Partner with cross-functional teams, including manufacturing, quality, regulatory, and R&D, to ensure that product design and manufacturing processes are fully compliant with quality standards and regulatory requirements during a manufacturing site transfer • Act as a liaison between design assurance subject matter experts and the manufacturing site team to ensure smooth communication and alignment during the site transfer process • Coordinate and support process validation activities (OQ/PQ) to ensure processes are fully validated in accordance with applicable standards and requirements • Partner with operations quality engineers to ensure design controls and PFMEA to DFMEA & EDO linkages are maintained. • Review and approve process validation protocols and reports and other technical documentation associated with the manufacturing site transfer • Ensure compliance of all practices to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented. • Assist with root cause analysis of identified issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities. • Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries. • Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule. **Education / Experience Requirements** • B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered). • 5 to 10 years of quality engineering or design assurance experience (preferably in the medical device industry). **Specialized Skills / Other Requirements** • ASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB). • Strong understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820. • Proficient in MS Office, and Minitab or other statistical softwares. • Strong organizational and time management skills to meet deadlines while managing multiple projects. • Strong analytical and critical thinking skills. • Proficient in technical report writing and review. • Strong verbal and written communication skills (English, proficiency in Spanish is preferred but not required). • Foster a positive culture of growth, collaboration, and achievement across the organization. \#LI-NR1 _At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._ _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: 877-880-8588 or Talent@Teleflex.com._ _Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, 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._