QA Technical Leader

1. NPI Quality Leadership:                                             
- Serve as Quality representative in all New Product Introduction (NPI) projects.                                            
- Ensure quality requirements are clearly defined and implemented throughout product development lifecycle.                                            
- Participate in DFM reviews to ensure design for manufacturability, reliability, and quality.                                            
- Ensure product and process readiness prior to production release.                                            
2. Risk Management & Quality Assurance:                                             
- Lead and facilitate risk management activities including:
+ DFMEA
+ PFMEA
- Risk analysis and mitigation planning.
- Ensure risks are identified, mitigated, and controlled before production launch.
- Drive preventive quality approach rather than reactive correction.                                       
3. Process Development and Validation:                                             
- Ensure proper implementation and approval of:
+ Control Plan.
+ Inspection Plan.
+ Work Instructions.
+ Quality standards for new products."                                            
- Review and approve validation activities including IQ, OQ, PQ.                                            
- Ensure manufacturing process capability and stability before mass production.                                            
4. Design Transfer & Production Readiness:                                             
- Ensure effective and compliant transfer from engineering to manufacturing.                                            
- Ensure all quality deliverables are completed prior to pilot and mass production.                                            
- Support pilot build, NPI Build, and production ramp-up activities.                                            
5. Customer Quality Interface for NPI:                                             
- Act as quality interface with customers during NPI phase.                                            
- Support customer audits, technical discussions, and quality reviews.                                            
- Ensure customer quality expectations and requirements are met.                                            
6. First Article Inspection (FAI / FAIR):                                            
- Ensure First Article Inspection (FAI) is planned, executed, and approved prior to production release.                                            
- Review and approve First Article Inspection Reports (FAIR) to verify compliance with:
+ Customer drawings.
+ Specifications.
+ BOM.
+ Assembly drawings.
+ Critical dimensions and characteristics.                                            
- Ensure ballooned drawings and full traceability between drawing requirements and inspection results.                                            
- Coordinate with Engineering, Manufacturing, and Supplier Quality to resolve any FAIR discrepancies.                                            
- Ensure FAIR approval is completed prior to pilot build exit or mass production release.                                            
- Maintain FAIR documentation as part of Device History Record (DHR) or product quality records.                                            
7. Continuous Improvement & Lessons Learned:                                            
- Drive lessons learned from NPI into future projects.                                            
- Support root cause analysis and corrective action during development phase.                                            
- Improve NPI quality performance and reduce launch risk.