Validation Engineer 1

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

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

                              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 multiplepriorities with least supervision

Specialized Skills / Other Requirements