Quality Engineer

Date: 27-Mar-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 3675

 

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

Principal Responsibilities

1. Generation and maintenance of MDD / MDR Technicial Files for medical devices. 
2. Ensure compliance of all practices to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced and change management is implemented. 
3. Understand the implementation of appropriate internal, national & international requirements and standard. 
4. Responsible for ensuring Technical Files are in compliance with relevant regulations and standards. 
5. Executive of Risk Management Activities as per EN ISO 14971
6. Support Regulatory Affairs with related submission and product registration. 
7. Apply technical solutions to quality improvement project.
8. Planning, protocol generation, testing execution and report generation for medical devices. 
9. Support Product Registration activities.
10.Undertake effective OSH measures to ensure compliance, within the workplace, with the Occupational Safety and Health Act 1994 and other legislative requirements.
 

Education / Experience Requirements

Qualification    :    
Degree in Science/Polymer Science or related Engineering field.  Good command of English.
            
Experience    :    
Preferable with experience in validations, risk management, R&D activities, as well as knowledge in regulatory requirements of medical devices. 
Experience in Medical or Pharmaceutical field will be an added advantage.

Specialized Skills / Other Requirements

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.

© 2021 Teleflex Incorporated. All rights reserved.