Validation Engineer 1

5 days ago


Kamunting, Perak, Malaysia Teleflex Full time

Expected Travel: None

Requisition ID: 13025

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, LMA, Pilling, QuikClot, 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

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

1.    Coordinate validation activities and ensure compliance with validation requirement while collaborating with site QA, RA, Production, Demand Planning, Engineering/Tooling and related functional departments
2.    Execute test validation method when required
3.    Review and execute process validation, including tooling/equipment/jigs related activities and testing
4.    Perform root cause analysis if found failure during validation execution
5.    Analyze manufacturing/assembly data and provide/suggest improvements when required.
6.    Conduct briefing and / or training on validation requirements for suppliers to ensure supplier meet expectations on validation for documentation purposes such as traceability and good documentation practice. (GDP)
7.    Interact with production, suppliers, and internal support department to ensure new qualified parts are ready for production use.
8.    Support suppliers for documentation improvement if needed
9.    Support Materials Support Specialist during material testing 
10.    Responsible for ensuring supporting documents from supplier is sufficient for validation activities and comply with Teleflex requirements.
11.    Responsible for communicating and updating the validation status to respective personnel and value stream members for mutual understanding.
12.    Ensure supplier's qualification comply to ISO-13485 requirement.
13.    Responsible for data verification in validation and ensure robustness. 

Principal Responsibilities
Education / Experience Requirements

Qualification      :   Degree in Engineering, Science or Math, Degree in Manufacturing, Polymer

Science, or equivalent

Experience :   1. Two to three years' experience in related field

The candidate has an engineering background in Medical Technology, Packaging, plastic or chemical engineering.

Must possess good technical writing ability including proficiency in Word, Excel, PowerPoint and QC tools

Should have up to date knowledge on the validation requirements, ISO standards, procedures and good knowledge in medical device requirements

Excellent written and verbal communication skills

Self-motivated and drive for excellent with good interpersonal skills for working across multifunctional teams

Ability to articulate issues related to validation and manage multiplepriorities 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.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. 
2025 Teleflex Incorporated. All rights reserved.



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