Senior Quality Assurance Executive

In this role as a Sr. Executive Quality Assurance (QA), you will have the following responsibilities: - Device Master File Compliance: Draft the Device Master File in alignment with Indian Medical Device Rule 2017 requirements to ensure full compliance for regulatory submissions and audits. - Clinical Data Collection and Compilation: Collect and compile data on device safety and performance from scientific journals and databases such as EMBASE, PubMed, and Cochrane to support regulatory submissions and product evaluations. - Technical Documentation and Regulatory Compliance: Assist in drafting technical documents like Biological Evaluations, Risk Management, and Usability Reports, complying with EUMDR 2017/745 regulations. - Quality Management System (QMS) Compliance: Understand and implement QMS standards following ISO 13485:2016 and Annexure IX of EUMDR 2017/745. Maintain and update all QMS documentation to ensure ongoing compliance. - Quality Documentation Management: Create, update, and manage company quality documentation including manuals, procedures, and records. Monitor and enforce consistent implementation of quality management systems in the organization. - Audit Management: Coordinate internal and external audits related to QMS and CE marking. Address non-conformance reports promptly and focus on continuous improvement. - Customer Complaint and Incident Management: Handle customer complaints by conducting root cause analysis and providing responsive solutions. Manage vigilance reporting and product recalls to maintain product integrity and customer satisfaction. The qualifications required for this position include: - Experience in Device Master File Compliance, Clinical Data Collection and Compilation, Technical Documentation, Regulatory Compliance, Quality Management System (QMS) Compliance, Quality Documentation Management, Audit Management, and Customer Complaint and Incident Management. - Familiarity with Indian Medical Device Rule 2017 and EUMDR 2017/745 regulations. - Strong understanding of ISO 13485:2016 standards and Annexure IX of EUMDR 2017/745. - Excellent communication and problem-solving skills to address compliance issues effectively. - Ability to work collaboratively with internal and external stakeholders to ensure regulatory compliance and product quality. Please Note: There are no additional details about the company provided in the job description.,