Job Title: Quality Technician
This role involves ensuring customer satisfaction by monitoring, controlling and improving all related customer processes. The position requires a customer interface for Quality metrics and improvement initiatives.
Main Responsibilities:
1. Support quality process definition, setup, verification and improvements.
2. Complete in-process testing on Product.
3. Complete weekly leak & burst testing on product to ensure product is sealed correctly as per the required specification.
4. Verification of Critical process parameters (CPP`s) & Line Clearance activities.
5. Conducting internal process audits to ensure conformance and effectiveness of the Quality System.
6. Supporting Audits by demonstrating product testing requirements & best practices.
7. Feedback and improvement on Customer 'Supplier Quality Issues'.
8. Prepare for and attend daily engagement process meetings.
9. Identify improvements through Quality review and meetings on Quality, Yield, flow, documentation, control etc.
10. Escalation of Quality Issues where necessary & conduct non-conformance investigations when required.
11. Perform weekly environmental monitoring sampling of the ISO Class 8 Cleanrooms.
12. Prepare and review sterile release packs (Endotoxin & Bioburden test reports).
13. Conducting & verifying releasing of sterile product.
14. Supporting SMT line first off verifications along with verifying line clearance activities.
15. Reviewing & approving unplanned maintenance activities when required across multiple assembly lines.
16. Determine Lot suitability for release by reviewing production logs and final batch records against product specifications, procedures and electronic data systems.
17. Review and approval of Design History Records (DHR) by obtaining and verifying the contents of DHR's against the relevant documentation requirements.
18. Interacting with manufacturing execution system (MES) & Oracle Agile systems daily to ensure products are assembled as per the required specification.
19. Work space compliance to Site requirements, ESD, MSD, Housekeeping (5S), Safety etc.
20. Assure ongoing compliance with quality and industry regulatory requirements.
21. Ensure compliance with Health & Safety Legislation and Regulations.
22. Key Performance Indicators:
23. Yields at Key Process Steps (