Validation Tooling Engineer (Contract)

Date: 19-Feb-2021

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3265

 

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.    Coordinate mould validation activities and ensure compliance to validation requirement.
2.    Prepare the validation plan and execution.
3.    Execute test validation method when required.
4.    Review and execute process validation, including tooling related activities and testing.
5.    Assist value stream in root cause analysis if found failure during validation execution.
6.    Analyse manufacturing/assembly data and provide/suggest improvements when required.
7.    Conduct briefing and / or training on mold validation requirement for supplier to ensure supplier meet expectation on mold validation for documentation purpose such as traceability and good documentation practice. (GDP)  
8.    Interact with customer (production), suppliers, and internal supporting department to ensure molded parts are ready for production use.
9.    Support supplier for documentation improvement.
10.    Support Tooling Specialist and Tooling/Mould Engineer during mold testing such as FAT and installation qualification at supplier site.
11.    Responsible to ensure supporting documents from supplier is sufficient for validation activities and comply to Teleflex requirement.
12.    Responsible to communicate and updating the validation status to respective personnel and value stream members for mutual understanding.
13.    Ensure mold qualification is comply to ISO-13485 requirement.
14.    Responsible for data verification in validation and ensure robustness.
 

Education / Experience Requirements

Qualification   :    
Degree in Engineering, Science or Math, Degree in Chemistry, Polymer Science,   Statistics or equivalent. 

Experience    :    
1.   Knowledge in Problem Solving and statistical techniques and computer experience.
2.   Two to three years’ experience in related field.
3.   Must possess good technical writing ability including proficiency in Word, Excel, PowerPoint and QC tools.
4.   Should have up to date knowledge on the validation requirements, ISO standards, procedures and good knowledge in medical device requirements.
5.   Excellent written and verbal communication skills.
6.   Self-motivated and drive for excellent with good interpersonal skills for working across multifunctional teams.
7.   Ability to articulate issues related to validation and manage multiple priorities with least supervision.

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.