QMS Specialist III

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 Management Systems Specialist 3 supports the development and Maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Also, the Quality Systems Specialist 3 is overall responsible for the document Control and Internal Audit Processes at the North American Distribution Center (NADC).

• Manage the document control lifecycle of all QMS documents, including availability of documentation, accuracy, distribution, training effectiveness, and periodic review.
• Manage, establish, monitor, and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business.
• Manage in developing and monitoring corrective and preventive action (CAPA) process internally.
• Provide training and mentorship to NC owners.
• Anaylzes problems, determines approach, compiles and analyzes data, and prepares reports/recommendations.
• Supports the management review process through the development and generation of quality system metrics and generates monthly data for those metrics. Helps management in creating QMR presentation slides for some QMS elements.
• Identify opportunities to continuously improve the quality system processes.
• Responsible for identifying, implementing, and reporting metrics to site leadership
• Ensure processes needed for the NCE system are documented and controlled.
• Maintain effective, efficient, and cohesive quality system processes which ensure compliance with internal requirements, as well as external (FDA, ISO, etc.) requirements and expectations.
• Develop, implement, and maintain meaningful NC/CAPA metrics to measure the quality system performance.
• 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.
• Manage and provide strategic oversight to the local QMS Audit program through creation of an improvement roadmap and detailed plan including communication
• Support organization and facilitation (front and back room) of FDA, Notified Body, and Supplier audits and inspections.
• Responsible for site External…