Asiatant Manager Quality
CurrentHandling overall quality control function: Supplier Quality, Process Quality with a total team size of 28, including 5 Executives & 23 Quality inspectors. .Streamlining the Auditing Quality Management System & Quality System Regulation (QSR) as per ISO 13485: 2016 & 21 CFR Part 820 Subchapter H. Complaints Handling, SCARs & related CAPAs, Change Controls, Deviations to ensure their timely closure with effective implementation.To handle & assist external / internal audits and its associated records. To assist in preparation & control of Device Master Records (DMRs).Overall preparation & Control of Work Instructions (WIs) and Quality Procedures (SOPs). Responsible for control of monitoring & measuring devices.Review & Control of Process Validation Protocol, Stability Protocol & Equipment Qualification Protocol (IQ, OQ & PQ documents).To ensure that Incoming, in-process & finished-goods lot inspection records are completing timely & sharing Rejection Report along with data analysis on Daily/Weekly/Monthly Basis.Imparts regular training session for subordinates.