Senior Quality Engineer

Date: 29-Apr-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 3861

 

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.    Ensure compliance to the Quality System Regulation (QSR), MDSAP, ISO 13485: 2016, MDD or EU MDR and other relevant Site Standards.
2.    Quality Management of IQC- control of incoming material, sampling, testing, disposition, reporting and record maintenance.
3.    Owner of RMS and MSDS.
4.    Manages the site non-conformance report
5.    Manage Supplier non-conformances to ensure timely closure and effective corrective actions to prevent re-occurrence.
6.    Support operations in addressing supplier related non-conformances.
7.    Conduct adhoc visit on supplier premises as and when needed.
8.    Where appropriate, provide relevant Quality support in achieving Site Operational, Financial and Continuous Improvement Goals in areas such as PIP’s and alternative supplier program
9.    Reporting of relevant Quality Metrics to Senior Management.
10.    Support Warehouse and Purchasing team on RTV (Return to Vendor) items in order to avoid cumulative supplier reject related.
11.    RMA (Return Merchandize Authorization) requisition from suppliers for defective lots detected at IQC and production. 
12.    Initiate, manage, and coordinate MRB activities 
13.    To ensure the implementation and maintenance, within the workplace, of an effective management for Occupational Safety and Health Act 1994 and other legislative requirements.
 

Education / Experience Requirements

Qualification    :    
Degree in Engineering, Science or related discipline.

Experience    :    
Minimum 3–5 years’ experience in Supplier Quality Engineering Role (ideally within the Medical Device Industry). 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 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.