Validation Engineer

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