Regional Quality Systems Liaison - APAC
Date: 20 Apr 2024
Location: Kamunting, 08, MY
Company: Teleflex
Expected Travel: None
Requisition ID: 9888
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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 Regional Liaison will lead implementation activities for a harmonized quality management system (1QMS) and aid in configuring and implementing an electronic quality management system platform (eQMS) at all facilities within the region.
Principal Responsibilities
• Provide regional support for the 1QMS and eQMS strategic initiatives.
• Serve as the key change agent in the region, communicating the project vision.
• Provide input/review training content for global roll out of harmonized QMS processes to ensure accessibility.
• Support translations of QMS documents and training as needed.
• Serve as the voice of 1QMS and eQMS in for facilities in the region, supporting training efforts, communications, gap assessment activities with local procedures, and change management activities.
• Lead change management activities within the region for 1QMS and eQMS.
• Work with local change analysists at facilities within the region to implement new and revised processes.
• Create a closed loop system to ensure consistent implementation across the organization.
• Assist in gap assessment activities with local procedures, escalating concerns from the facilities to the 1QMS team.
• Lead or support additional local or global projects as assigned by Quality and Regulatory Leadership.
Education / Experience Requirements
• B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered).
• 2 to 5 years of experience in quality or compliance (preferably in the medical device industry).
Specialized Skills / Other Requirements
• Basic understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.
• Proficient in MS Office.
• Strong organizational and time management skills to meet deadlines while managing multiple projects.
• Strong analytical and critical thinking skills.
• Proficient in technical writing and review.
• Strong verbal and written communication skills.
• Foster a positive culture of growth, collaboration, and achievement across the organization
Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.
Teleflex is an equal opportunities employer
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.