Job Description

You are responsible for:

1. Producing and completing Supplier Quality Engineering Activities and related documentation under direct supervision.
2. Assist in Qualification of Parts, identification of supplier processes for CTQ’s, Supplier Process Control plans to ensure product quality; by authorizing, supplied parts meets specifications, and the control limits/tolerances for CTQ parameters are met.
3. Assist in qualifying and sustaining sub-processes of supplier including supplier audit.
4. Support R&D during product development by providing insights on manufacturability and integration and work as quality gatekeeper for all documentation delivered as part of supplier transfer activity.
5. Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes. 
6. Drive supplier improvement via SQIP (Supplier Quality Improvement Plans)
7. Lead Supplier Change Notice process with support from Engineering, Quality Engineering / Assurance, Regulatory, ME, R & D, Clinical, etc.
8. Performing data analysis and reporting for Supplier Quality Performance Monitoring, assisting in the development of Quality processes relating to Supplier Quality Control’s.
9. Conduct supplier audits and supplier qualification.Experience with CPK, APQP, MSA, FMEA, Process Capability Statistics in relation to Six Sigma, which is essentially process optimization, understands QSIT (Quality System Inspection Technique), serve as a Quality interface to suppliers supporting quality and productivity goals, proactively monitoring, measuring product/process quality, performance trends, and troubleshooting of production/release issues.
10. Monitor DPPM, FPY, FDR, LAR, SCAR ageing and effectiveness and take appropriate actions to maintain them within acceptable limits.
11. Supports Design for Excellence (DfX) collaboration between R&D and Suppliers
12. Critical to Quality characteristics flow down to Suppliers, Supports Quality Engineering capability assessments of potential new suppliers.
13. Support Supplier improvement and development on APQP.
14. Supports with Additions/Changes/Deletion to Approved Supplier List, Analysis of defects for determining if supplier caused and then notified. Part Submission Warrant plans, deliverables, line release and completion.
15. Technical deep dive analysis to troubleshoot issues, carry out full root cause analysis and ensure preventive actions to avert the issues.