Director of QA

Date: 18-Jun-2022

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 6113

 

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.    Overall responsibility for the following functions: Quality Assurance, Calibration, Supplier and Raw Material Management, Documentation, Microbiology and Customer Complaint Handling, CAPA and audit.
2.    Establish and maintain the Quality Management System. Report on the performance of the Quality Management System during Management Review.
3.    Appointed as Management Representative in ensuring that Quality System is established, implemented, Maintained and is effective in accordance to International Standards such as ISO-13485 latest revision, MDSAP, QSR-FDA, MDD or EU MDR, CMDR, J-PAL, Ordinance 169:2004, Malaysia MDR and GDPMD.
4.    Ensure that the company’s products are processed in accordance to relevant external and internal standards.
5.    Interface the plant with customers and other bodies in matters affecting quality and setting of standards for product and process.
6.    Approves Quality Manual, Procedure Manuals, Quality Agreements, Drawings/Specifications, Change Request Notes, Operator Instructions, Experimental Protocols, lots of product or material, deviations for non-conforming material and others as specified in relevant procedures.
7.    To ensure the implementation and maintenance, within the division, of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
 

Education / Experience Requirements

Qualification    :    
Statistical Control, Quality System Regulation

Experience    :    
Must have at least 10 years in Quality Management with exposure to medical device industry.

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.