Quality Engineer II

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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.

The Quality Engineer will provide support for Quality and Operations, interact with cross-functional team members and internal customers and provide support for Engineering, Quality Systems, Projects and Process engineering.

Specific activities may include but are not limited to:

• Nonconformance and CAPA coordination and processing;
• Service complaint investigations;
• Process & product validations;
• Customer Notification of Change evaluations;
• Internal & external auditing
• Front room and back-room audit support;
• Statistical analysis
• Quality and continuous improvement projects
• Assure compliance with applicable Teleflex Global & local Procedures and Policies

• Nonconformance (NC) and CAPA processing – independently lead quality activities with respect to Conductor Material Review Board coordination; inspection methods; NC containment/correction/closure; and CAPAs; and drive improvement through analysis of trend data. Ability to resolve non-conformances.
• Serve as CAPA Champion as needed:
  Coach and support CAPA Owners to ensure compliance; monitor weekly reports to act on upcoming due dates; run CRB meetings (record minutes, track actions, elevate to ECRB, and archive records); and train new CAPA Owners. Serve as CAPA Owners and Phase Owners as assigned.
• Service Complaint Investigations – Primary investigator and facilitator for Conductor complaint investigation, confirmation, and corrective actions. Act as primary customer contact on complaint communications. Drive improvement based on trends.
• Strong understanding of Supplier Quality activities including supplier onboarding, supplier evaluation, supplier performance monitoring, supplier corrective actions (SCAR). Can recognize and resolve nonconformances within the system.
• Process Validations – guide and review protocol development, validation implementation and report review an acceptance;
• Quality & Cost Improvement Projects – lead and participate on key projects for product or process improvements;
• Maintain company compliance with Quality System Regulations and ISO 13485 standards.
• Experience with FDA and ISO inspections and registration. Able to interpret general audit requests to identify relevant SOPs, records, etc.
• Documentation Control – perform Product Specification reviews. Compiles and writes procedures, work instructions, training material, and conducts training sessions on…