Internal Auditor

3 weeks ago


Panipat HR IN BAMC MEDICAL LIMITED Full time

Primary role - The Internal Auditor is responsible for evaluating the effectiveness of internal controls processes and systems to ensure compliance with applicable regulatory quality and company requirements This role is critical in maintaining a compliant and efficient Quality Management System QMS in accordance with standards such as ISO 13485 CDSCO -13485 CE BIS QSR and other applicable global regulations for medical devices Develop and maintain an internal audit schedule based on risk assessment and regulatory requirements Plan prepare and conduct internal audits of manufacturing assembly quality and support processes Conduct process product and system audits in various departments production engineering store Warehouse calibration and validation BIS - Submitted and maintained product registrations with BIS CDSCO - Submitted and maintained product registrations with CDSCO ISO - 13485ISO 13485 Medical Devices - Quality Management Systems Prepare all the relevant documents and records Developed SOPs per ISO 13485 and regulatory requirements Risk CAPA - Root Cause Analysis Complaint Handling PMS Change controls Deviations NC OOS Out of Specification CAPA FSCA Field Safety Corrective Action Analyzed customer complaints deviations and trends to implement effective CAPA 3 Investigated NCs and customer complaints using CAPA and root cause analysis tools Software installation in various machine equipment s Like - Monitor ECG Pulse OXI Meter etc Core Responsibilities - 1 ISO 13485 CDSCO CE BIS 2 LEAN and Six Sigma principles for process improvement audits 3 QMS Documentation Technical File DMF RMF 4 Managed QMS documentation and change control processes from development to launch Job Type Full-time Pay 20 000 00 - 40 000 00 per month Benefits Cell phone reimbursement Food provided Provident Fund Work Location In person


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