Mageswari A

Experience

1. Member of Technical Staff

   HCLTech

   Feb 2021 — Present · Chennai, IN

   Key Skills: ISO 13485, ISO 14971, eMDR, US FDA, 21 CFR 803, 21 CFR 820.198, TrackWise, Salesforce, SAP, MS Office, Good Documentation Practices • Evaluate incoming complaint information and maintain record in electronic QMS database – TrackWise (Infusion Pumps)/ Salesforce (Dispensing Solutions). • Verify the service history records, manufacturing quality notification with SAP NetWeaver and perform follow up activities to obtain additional information if required. • Mapping appropriate IMDRF codes against different failure modes. • Performing Good Faith Efforts (GFE) when required to gather additional data as needed to support the investigation process. • Investigate the complaint and write CHR, DHR, investigation summary based on technical product analysis and risk review results. • Determine the reportability of the complaint to the regulatory body (FDA) using MDR Guidelines and sending the eMDR to FDA if the complaint is found to be reportable. • Maintaining CAPA for process improvements and to achieve defect free deliverables. • Remediating the retrospective complaints and reviewing them for reportability, create supplementary eMDR if required and submit to FDA. • Training and mentoring the new resources on the product and process of complaints handling.

Education

• Adhiparasakthi College of Engineering

  Bachelor of Engineering - BE

  2014 — 2018