Quality Engineer 1

Position Summary

1. Review, coordinate and approve validation and verification document of proposed materials, packaging or finished products to ensure their quality and functionality.
2. Support in coordinating process, equipment, spreadsheet, software, and test method validation activities for Teleflex Kamunting site.
3. Review process, equipment, test method, spreadsheet and software validation protocol and final report.
4. Support supplier and change management programs.
5. Assist in Statistical process control and process capability assessment in the validation program.
6. Undertake margin expansion, PPV and CIP’s opportunities for site and corporate where necessary in the are of material or packaging substitutions initiatives and cost reduction where applicable.
7. Liaise and coordinate with suppliers, R&D, Global Packaging and QA/RA on regulatory requirements.
8. Conduct briefing and / or training on validation requirements for suppliers to ensure suppliers meet expectations on validation for documentation purposes such as traceability and good documentation practice. (GDP)
9. Support suppliers for documentation improvement if needed
10. Responsible for ensuring supporting documents from supplier is sufficient for validation or verification activities and comply with Teleflex requirements.
11. Responsible to communicate and update the validation or verification 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 or Diploma in Engineering, Science or Math, Degree in Chemistry, Polymer Science, Statistics and Certificate in Quality Engineering.

Experience:
•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 multiple priorities with least supervision

Specialized Skills / Other Requirements