Binit Vaghani Email & Phone Number

•Enthusiastic self-starter and self-motivated collaborative team player, Quality Engineer with Masters in mechanical engineering and 7+ years of experience in medical device industry with emphasis on quality engineering, manufacturing and process improvement. •Extensive experience with supplier quality activities (supplier audits, internal audit, supplier corrective action requests (SCAR), supplier scoreboard and supplier related CAPA activity) and incoming quality/inspection control.•Managed and implemented First Article Inspection, incoming inspection, Certificate of Conformance, non-conformance to supplier (SCAR) through Corrective Action Board (CAB).•Detailed experience in areas of Deviation, Non-conformance, EU MDR Gap assessment for regulatory compliance.•Experience with Product development, DOE, process capability, SPC, root cause analysis, Test Method Validation (MSA, Gage R&R), CAPA, PFMEA, DFMEA, and QMS.•Working knowledge of ISO 9001, ISO 13485, 21 CFR 820, GDP, GMP and other relevant standards and regulations.