Quality Engineer
Current• Responsible for providing technical assistance to Quality and Manufacturing groups.• Work with internal and external groups to ensure that proper definition of quality expectations and work on product and process quality.• Work cross functionally with various teams i.e., Engineering, Manufacturing, Regulatory and Customer support to execute various quality process and promote continuous improvement.• Support risk management activities by updating FMEA’s.• Responsible for Quality data reporting, data analysis, perform and monitor KPI’s for process improvement.• Lead containment activities, cross functional root cause analysis and CAPA.• Ensure effective resolution of customer quality issues & timely closure of SCARs.• Collaborated with key suppliers on qualification, process capability, quality issues, and process improvement.• Reviews Protocols, Process and Product Validations.• Lead Quality Support for the disposition of material via NCR’s.• Supplier 8D corrective action issuance and response review.• Supplier and customer engagement relating to manufacturing capabilities and design.• Review VMSI and supplier Quality Management Systems (QMS) for conformance to ISO 9001 and ISO 13485 standards.