Roles & Responsibilities – QA Executive

• Prepare and maintain QMS and technical documentation as per ISO 13485 and MDR/CDSCO requirements

• Support CE marking documentation and design dossier preparation for new products

• Ensure implementation and maintenance of Quality Management Systems across manufacturing processes

• Coordinate internal and external audits and support audit compliance activities

• Maintain supplier records, batch records, and QA documentation

• Review and issue BMR (Batch Manufacturing Records)

• Handle deviations, CAPA, and root cause analysis for complaints and audit findings

• Monitor validation, calibration, stability, bio burden, and fumigation schedules

• Prepare and monitor process validation and machine validation activities

• Coordinate with different departments regarding quality system requirements

• Maintain QA records, QC reports, and document control activities

• Support management review meetings by providing QA/QMS reports and records

• Monitor implementation of corrective actions and system improvements

• Support risk management analysis, post-market surveillance, and field safety corrective actions

• Participate in continuous improvement and product development activities

• Raise change notes and suggestions for process improvement

• Conduct weekly verification and monitoring of departmental quality activities

• Maintain stock and control of printed quality documents