MDR Process Engineer (Contract)

Date: 11-Jan-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 3220

 

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.    To Perform retrospective review and ensure current process qualification/validation is adequate to meet Quality System and regulatory requirement.
2.    Undertake qualification/re-validation for process, report preparation and implementation within the predetermined MDR timeline.
3.    Develop/Maintain PFMEA documentation in liaison with PFMEA team to meet regulatory and ISO compliance.
4.    Support R&D to ensure compliance to product performance standard bt performing qualification for dimensional changes per new/revised ISO standard requirement.
5.    Responsible for initiation of real time protocol, report and sample preparation for legacy devices.
6.    To ensure all production documentation, procedures and specification are adequate and adherence to current manufacturing.
 

Education / Experience Requirements

Qualification    :    
Degree in Polymer Science or related Engineering field or Industrial Chemistry.
Computer knowledge will be an added advantage.
            
Experience    :    
Minimum 2 - 3 years’ experience in a manufacturing environment, preferably in Medical devices manufacturing environment.
Experience in Minitab software is added advantage.
            
 

Specialized Skills / Other Requirements

Other Competencies/ Skills   :    
Computer literate
Communications skills
Interpersonal skills
Productivity and Problem-Solving Technique.
 

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.

© 2020 Teleflex Incorporated. All rights reserved.