Quality Engineer , Product Quality Assurance

Quality Engineer 2, Product Quality Assurance

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 .

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 Guide Liner™ and Turnpike™ Catheters, Ringer™ Perfusion Balloon Catheter, AC3 Optimus™ and AC3 Range™ Intra-Aortic Balloon Pumps and the OnControl™ Powered Bone Access System.

Teleflex’s product portfolio now also includes Passeo™-18 Lux™ Peripheral Drug-Coated Balloon Catheter, Pantera™ Lux™ Drug-Coated Balloon Catheter, Orsiro™ Mission™ Drug-Eluting Stent, the PK Papyrus™ Covered Coronary Stent, and more. 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.

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 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 and present 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.

• BS Degree in Engineering (or related technical field)
• 2-5 years related (medical device preferred) experience
• Experience with statistical analysis using Minitab and/or Microsoft Excel.
• Quality Assurance (21
  
  CFR
  820, ISO
  13485) and Risk Management (ISO 14971) experience desired
• Experience with Corrective Action and Nonconformance process

• Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required
• Experience with Corrective…