QMS Specialist II

Expected Travel: None

Requisition ID: 11018

 

About Teleflex Incorporated

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™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ 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 teleflex.com.

 

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.

Position Summary

The Quality Systems Specialist II 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 II assist with managing the document Control and internal audit process at the North American Distribution Center (NADC). 

Principal Responsibilities

•    Develop and maintain the local QMS procedures and work instructions to maintain compliance to applicable regulations, standards, and business requirements that will evaluate the health and effectiveness of internal processes and procedures
•    Assist in developing and monitoring corrective and preventive action (CAPA) process internally.
•    Assist in facilitating internal training on quality assurance requirements, processes, and procedures.
•    Provide training and mentorship to NCE owners.
•    Ensure processes needed for the NCE system are documented and controlled.
•    Assist in management of site Document Control System.
•    Manage assigned portions of the quality system to ensure overall system effectiveness.
•    Supports management review process through the development and generation of quality system metrics and generates monthly data for those metrics. Help the management in creating QMR presentation slides for some QMS elements. 
•    Identify opportunities to continuously improve the quality system processes.
•    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.
•    Independently perform internal audits at regular intervals to ensure compliance to the QMS SOP and WI for each department.
•    Supports organization and facilitation (front and back room) of FDA, Notified Body, and Supplier audits and inspections.
•    Responsible for site External Standards process
•    Partners with Regulatory and/or departments to execute compliance-related strategies.
•    Partners with technical teams to ensure quality system enables success while maintaining compliance.
•    Initiate, prioritize, and lead optimization opportunities to increase effectiveness and efficiency.
•    Implement corporate strategic initiatives and execute at a site level.
 

Education / Experience Requirements

•    Bachelor’s degree in engineering, business, logistics or operations is preferred or 3+ year’s equivalent specialized experience with emphasis in Quality. 
•    3+ years of relevant experience in Medical Device environment and/or Quality Management Systems.
•    Ability to work in a cross-functional team environment, manage multi-tasking, and be disciplined in completing tasks on schedule.
•    Experience with regulatory inspections/audits
•    Experience and knowledge of risk management and CAPA systems
•    Certifications (ASQ CQA / ASQ CMDA / Exemplar Global / AAMI, etc.) preferred.
•    Experience with Agile or similar quality management systems preferred.
•    Experience with SAP a plus.<