Process Development Engineer (SPCR-216)

Date: 01-Sep-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 4422

 

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.    Responsible for QMS activities related to product transfer as sending site and ensure adequate controls are in place.
2.    Responsible for compilation of sending site historical quality performance data, quality related documents and data to support receiving site and project documentation compilation.
3.    Work with sending site sustaining team to support receiving site with regards to product qualification done at sending site, and the quality related testing of transfer products.
4.    Support receiving site on transfer product new inspection method or testing method conversion development.
5.    Work with sending site sustaining team and lead the change control alignment discussion for transfer product.
6.    Responsible for material qualification (KMT manufactured and purchased finished goods under KMT Creed project scope) with supporting on FAI report for re-branded materials.
7.    Work with sustaining team, supplier quality engineer and material suppliers on development of re-branding material.
8.    Ensure the following deliverables are achieved as per the Teleflex procedure TG-000080.
9.    Identifying any risks and develops mitigation plans and communicating these to the Program Leader.
10.    To ensure the implementation and maintenance, within the department, of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
11.    Ensure Program conforms to the Quality System Regulation (QSR), CMDCAS, MDD 93/42/EEC, MDR, ISO 13485 and other relevant Standards.
12.    To ensure project are completed on time. 
13.    Perform any other relevant and related responsibility that may be assigned from time to time required by superior.
 

Education / Experience Requirements

Qualification   :    •    Minimum degree holder in Engineering, Science or Polymer disciplines. 
Experience     :    •    Minimum 3 - 5 years’ experience in medical device manufacturing environment, with working experience in quality department.

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.