Quality Engineer II **Date:** Jun 27, 2024 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** :10586 **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** The Quality Engineer II will be responsible for cross-functional quality assurance, quality management/compliance, quality control, and activities associated with all Teleflex products and processes with a focus on manufacturing activities. In support of Corporate Quality Objectives, the incumbent will contribute, manage, and drive improvement in 5 main areas of the Quality Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection Improvements; Perpetual Audit readiness; Product Complaints identified as manufacturing related; and Quality Improvement efforts related to Global or Local initiatives, such as Cost Improvement Projects. Additionally, the Quality Engineer II will support the Operations, Engineering, R&D, and Post Market Surveillance team activities to ensure that product quality and services are achieved and maintained. **Principal Responsibilities** • Nonconformance (NC) and CAPA processing – lead quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and drive improvement through analysis of trend data. • Support Incoming & In-Process Inspection teams. • Support the value stream with investigations required for field corrective actions including risk evaluation. • Participate in internal audit activities and support supplier corrective actions as needed. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits. • Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and process run sheets. • Documentation Control – perform change controls (ADC/ECR/ECOs) as needed. • Training – Perform QA training certifications on new production operators as needed. • Support Engineering with new product development with quality planning, risk evaluation, and validation. • Perform any additional QA tasks, as assigned by QA Manager. • Maintain compliance with Teleflex Global & local procedures and policies. • This position requires direct contact with an implantable device. ☐ Yes ☒ No **Education / Experience Requirements** • Minimum 4-year degree in an engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc. • Minimum 2-3 years experience of quality and/or related manufacturing/engineering role, prefferably in a manufacturing site. • Quality system management and deployment experience preferred. • Problem-solving and quality improvement, including quantitative methods. • Validations (product and process IQ/OQ/PQ). **Specialized Skills / Other Requirements** • Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements. • Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required. • Working knowledge and/or experience with SAP and AGILE is strongly preferred. • Good listening, verbal, and written communication skills • Excellent interpersonal skills with a demonstrated ability to work in a team environment. • Ability to prioritize and adapt to shifting priorities. • Ability to work independently with limited supervision. \#LI-LM1 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._