QMS Engineer

Date: 11-Jan-2022

Location: Kulim, 02, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 5134

 

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

•    Support Assistant QA Manager for the maintenance of the Quality Management System ensuring that the manufacturing organization complies with the International Standards e.g ISO13485 and US FDA regulations
•    Manage NC activities. Keep up with current manufacturing trend that concern with product quality. Provide analysis and review trending, investigation, correction, and corrective action for the NC.
•    Motivate and display leadership by displaying Teleflex Core Value
•    Coordinate the customer complaint activities. Perform analysis and review the trending, investigation, correction, and corrective action taken for the complaints. 
•    Coordinate the Risk Evaluation activities. Perform analysis and review the trending, investigation, correction, and corrective action taken for the RE. 
•    Support the Product registration documentation preparation upon request by the RA department 
•    Support in preparation internal/ Corporate/External audit activities. Conduct quality system audit
•    Assist with training and quality awareness 
•    Undertake special project as required and contribute to continuous improvement activities
•    Perform any other relevant and related responsibilities that may be assigned from time to time as required by superior.
•    Timely Escalation and Reporting
•    Work with the cross functional team to drive Site Objectives
 

Education / Experience Requirements

•    DEGREE IN MANUFACTURING / ENGINEERING / MATHEMATICS / APPLIED SCIENCE/MANUFACTURING ENGINEERING.
•    ISO 13485 auditor certification is an added advantage.
•    Minimum 1 years relevant working experience in Medical Devices manufacturing environment.

Specialized Skills / Other Requirements

•    Must be able to communicate fluently (written and verbal) in English and Malay Language. 
•    Knowledge in ISO 13485 and 21 CFR part 820 Quality Management Systems
•    Leadership and good communication skills
•    Meticulous at work and result oriented.
 

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.