Quality Engineer 1

Date: 4 Jul 2024

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 10435


About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. 
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare.  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.    Implement QA activities as per established procedures and maintain compliance in the designated manufacturing areas and warehouses.
2.    Supervise QA activity in designated manufacturing area and warehouse.
3.    To ensure online activities are carried out as per procedure/specifications.
4.    To ensure products are released on timely basis meeting customer and regulatory requirements 
5.    Preparation and publication of Quality analytical reports on timely basis
6.    Organize Quality meetings on regular basis with relevant departments
7.    Raise process non-conformance report or CAPA wherever required.
8.    Support manufacturing in CAPA investigation and customer complaints whenever necessary
9.    Verify corrective actions for CAPA and follow up on effectiveness of corrective actions   
10.    Train Senior Final Audit Supervisor (if applicable)/QA Auditors.  
11.    To highlight to QA Manager on unusual trends or defects.
12.    To ensure the relevant procedures are reviewed and revised to current Quality System requirements.
13.    To conduct internal audits /spot checks in production areas when required.
14.    Ensure DHR is reviewed prior to final release and certification. 
15.    To ensure the implementation and maintenance within the workplace of an effective management for occupational safety and health consistent with the requirements of Occupational Safety and Health Act 1994 and other legislative requirement in the workplace.
16.    Coordinate Quality Improvement Project
17.    Coordinate Ship Hold for the finished goods when required.
18.    Review and verify shipment list and certificates.
19.    Coordinate and monitor archiving DHR activity.
20.    Control and release of product at Final Audit and Final Pack.
21.    Work in hand with warehouse team in ensuring safe and good quality finished goods is distributed to customers.
22.    Manage, coordinate and monitor soak test activity.

Education / Experience Requirements

Qualification    : 
Degree in Science (Material, Polymers, Biology, Health Sciences or Chemistry or Quality Management System)

Experience    :
Minimum 5 years’ working experience in a manufacturing environment. 
Training in Lean Six Sigma or Six Sigma black belt and problem solving tools is 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, 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.