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Form of workJob Description
Responsibilities:
- Have a proven expertise in dealing with PCBA, PCB development and functional testing , SMT components.
- Certified in ISO 13485: 2016 and /or 21CFR Part 820A Certified IPC Specialist; has thorough knowledge of SMT process, electronic components, and electrical assemblies.
- Producing and completing Supplier Quality Engineering Activities and related documentation under direct supervision.
- Assist in Qualification of Parts, identification of supplier processes for CTQs, Supplier Process Control plans to ensure product quality; by authorizing, supplied parts meets specifications, and the control limits/tolerances for CTQ parameters are met.
- Assist in qualifying and sustaining sub-processes of supplier including supplier audit.
- 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.
- Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes.
- Drive supplier improvement via SQIP (Supplier Quality Improvement Plans)
- Lead Supplier Change Notice process with support from Engineering, Quality Engineering / Assurance, Regulatory, ME, R&D, Clinical, etc.
- Performing data analysis and reporting for Supplier Quality Performance Monitoring, assisting in the development of Quality processes relating to Supplier Quality Controls.
- 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.
- Monitor DPPM, FPY, FDR, LAR, SCAR ageing and effectiveness and take appropriate actions to maintain them within acceptable limits.
- Supports Design for Excellence (DfX) collaboration between R&D and Suppliers Critical to Quality characteristics flow down to Suppliers, Supports Quality Engineering capability assessments of potential new suppliers.
- Support Supplier improvement and development on APQP.
- 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.
- Technical deep dive analysis to troubleshoot issues, carry out full root cause analysis and ensure preventive actions to avert the issues.
