Quality 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.

Growth, Culture, People and Careers: this is the Teleflex Advantage. The Quality Specialist provides support and leadership for quality related processes, including but not limited to the Global Ship Hold process, audit process management support and quality systems meetings and forums, and maintains control of the NADC Quality Hold Cage. Additionally, the Quality Specialist will monitor and analyze quality restricted material within the distribution center to perform trend analysis and opportunities for improvements.

• Quality system compliance to ISO 13485, ISO 9001, 21
  
  CFR 820 and Medical Devices Regulations
• Governance and management of the Global Ship Hold process, SME for Ship Hold process, including but not limited to:
  • Manage initiating ship holds on behalf of non-Agile PLM sites.
  • Manage completion of stock assessment/verification (Physical verification of impacted stock) in collaboration with DC operations.
  • Manage and submit stock assessment quantities in Agile.
  • Manage and oversee the completion of any local restriction activities in relation to ship holds.
  • Manage ship hold disposition confirmation activities.
  • Manage and verify and resolve discrepancies of product quantities at all stages of the ship hold process.
  • Incorporate DC Finance, DC Demand Planning, etc. as applicable in the completion of disposition activities.
  • Manage reconciliation and provide any required documentation to support closure of each phase of the product ship hold and the subsequent closure 3PL/DC.
  • Manage and review ship holds to ensure all ship hold DC tasks have been completed and closed.
  • Managing unauthorized ship hold releases in SAP.
  • Manage completing product batch reports for ship holds in SAP and Agile.
  • Governance of all products contained within the Quality quarantine cage.
• Responsibility for Administration and oversight of quality systems processes including but not limited to:
  • Maintain documentation and communications with the Field Corrective Actions (FCA) Team
  • Distribution Center (NADC) audit process Internal Audit support
  • ISO / Regulatory authority support
• Lead / support internal audits
• ISO / FDA / etc. Regulatory authority support
• Assist the NADC with resolution of local quality issues
• Support QRB (Quality Review Processes) & MRB (Material Review Board) processes
• Manage and complete sample requests for external clients.
• Manage with all Nonconformance sort activities.
• Manage restricting and quarantining nonconforming products.
• Verifying and updating essential product information in SAP and Blue Yonder.
• Providing Global Operations with visibility reports in relation open product ship holds
• Provide KPI metric reports periodically and on request.
• Own and drive metrics to become a key player in the development of processes to enable and support both the gathering and improving of…