QMS Executive

Job Description

Responsibilities: Overall responsibility for certification requirements of the Quality Management System (QMS) as per ISO 9001 and 13485 Ensure that all documents and procedures are up-to-date and followed by all employees. Ensure archival of records at regular intervals Design and development stage: Coordinate for on-time completion of all records, timely updates to hazard-risk analysis and risk assessment files, liaise with 3rd party for design verification and validation testing (IEC 60601 and others as relevant). Coordinate for Design transfer: oversight during design transfer stage Vendor quality: Participate in the vendor-associated activities like reviewing the vendor documents and annual vendor evaluation Plan and conduct internal audits, Take appropriate corrective actions on identified problems. Coordinate with internal teams to collect monthly KPIs and prepare Management reviews Overall responsibility for certification requirements of the Environment Management System (EMS) as per ISO 14001 Documentation and records management and other activities (including training and coordinating for hazardous waste management) as per set environment objectives. Requirement: Knowledge on ISO 13485: 2016, ISO 9001:2015, ISO 14001: 2017. Internal Auditor certificate in any of the mentioned standards. Knowledge on CAPA, Root cause analysis, and Data Analysis Experience in Medical Device Industries Knowledge on ISO 14971:2019 Risk Management Communication Skills Show more Show less