Sr. Quality Assurance Executive

Role & responsibilities

1. Device Master File Compliance
• Draft the Device Master File to align with Indian Medical Device Rule 2017 requirements, ensuring full compliance for regulatory submissions and audits.
2. Clinical Data Collection and Compilation
• Collect and compile data related to device safety and performance from scientific journals and databases, including EMBASE, PubMed, and Cochrane, to support regulatory submissions and product evaluations.
3. Technical Documentation and Regulatory Compliance
• Assist in drafting technical documents, including Biological Evaluations, Risk Management, and Usability Reports, in compliance with EUMDR 2017/745 regulations.
• Prepare and manage technical files for certification audits to meet EUMDR 2017/745 standards, ensuring that all documentation is thorough and accurate.
4. Quality Management System (QMS) Compliance
• Ensure thorough understanding and implementation of QMS standards as per ISO 13485:2016 and Annexure IX of EUMDR 2017/745.
• Maintain and update all QMS documentation, including manuals, procedures, and policies, to ensure ongoing compliance with quality standards.
5. Quality Documentation Management
• Create, update, and manage company quality documentation, ensuring that manuals, procedures, and records are maintained accurately.
• Monitor and enforce consistent implementation of quality management systems across the organization.
6. Audit Management
• Coordinate internal and external audits, including those conducted by notified bodies, focusing on QMS and CE marking.
• Address any non-conformance reports promptly and efficiently, working toward continuous improvement.
7. Customer Complaint and Incident Management
• Handle customer complaints through root cause analysis and responsive solutions, addressing vigilance reporting and managing product recalls as necessary to maintain product integrity and customer satisfaction.

Preferred candidate profile

• Proficiency in regulatory requirements (Indian Medical Device Rule 2017, EUMDR 2017/745, ISO 13485:2016).

Perks and benefits