Senior Quality Engineer
Tata Consultancy Services Limited
Total years of experience :10 years, 4 Months
Contributing my performance as a team member to ensure process operations.
Preparation Risk Analysis & Fault tree Analysis documentation.
Document, review, evaluate and investigate responses on product complaints.
Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
Working on complete CHS process including Product Inquiries (PIs) Intakes, Complaints & PI closure in Track wise
Working on NCRs & CAPA for Hip implant recall and Material Analysis for the returned products.
Facilitating regulatory reporting, eMDRs & eMDVs for FDA Submission.
Connect with vendors, regarding product quality and production process. And also provide Vendor rating for their continuous improvement.
Effectively evaluate the IQC (incoming quality Control) and OQC (outgoing Quality Control)
Implement production and process improvement techniques to enhance the total productivity. (5’ S, FTA, PPAP, PFMEA & FMECA, MSA, QFD etc.)
Statistical study of IPQC (In-process Quality control) by using DMAIC &7QC tools, QFD, SPC to determine & eliminate the causes which affect process.