· To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 13485 · Organizing internal & external audits including notified bodies audits related to quality management system and follow up of non-closure reports. · Dealing in customer complaints, investigating, root cause analysis and replying, vigilance reporting & recall. · MRM- Organizing & follow up actions from previous meetings. · Review & modification in all the SOPs & manuals. · Master list of records- Establishment & updating. · Master list of documents- Establishment & updating. · Deviations- Follow up & records · Preparation & evaluation of risks for the devices · Corrective & preventive actions- Corrections, implementations & maintenance. · Calibration of equipment’s and machines of production & quality control.
📌 QA / QC Executive (Gurugram)
🏢 9M Medical System
📍 Gurugram
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