Quality Engineer , Product Quality Assurance

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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™ LMA™ Pilling™ Quik Clot™ Rüsch™ Uro Lift™ 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 .

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.

Teleflex is seeking a Quality Engineer 1 to join our team! This role supports the Product Quality Assurance team analyzing post-market data and potential product quality issues for commercialized devices. Accountable for a broad range of technical assignments in the Quality Assurance area under general supervision and working with cross-functional investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ISO 13485 and 14971.

• Create, investigate and/or manage nonconformances, as well as associated ship holds and product disposition.
• Investigate, compile and report on information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products is warranted.
• Work closely with Manufacturing sites, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory to investigate and document quality issues.
• Assist with compilation and analysis of product quality metrics for presentation to Global and business unit leadership.
• Utilize basic statistical techniques to identify rates, changes in trends or estimated occurrences based on bench and field data.
• Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to respond to Product Quality issues.
• Assist during regulatory inspections and/or audits as required.
• Utilize SAP, Agile and other systems as warranted for data input and quality record maintenance.
• Communicate and elevate Quality issues appropriately to QA Manager and address other items as assigned by Manager.
• Adhere to and ensure compliance with the Teleflex Code of Ethics, all company policies, rules, and procedures.

• BS Degree in Engineering (or related technical field).
• 0-2 years related (medical device preferred) experience.

• Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.).
• Positive attitude and ability to operate and communicate effectively with multiple teams & leadership.
• Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve…