Validation Engineer

Date: 9 Apr 2024

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 9939


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


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 validation activities and ensure compliance to 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.    Analyse manufacturing/assembly data and provide/suggest improvements when required.
6.    Conduct briefing and / or training on validation requirement for supplier to ensure supplier meet expectation on validation for documentation purpose such as traceability and good documentation practice. (GDP)
7.    Interact with production, suppliers, and internal supporting 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 testings 
10.    Responsible to ensure supporting documents from supplier is sufficient for validation activities and comply at Teleflex requirements.
11.    Responsible to communicate 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. 
14.    Scope – covers all Procurement related projects in APAC sites

Education / Experience Requirements

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