Job Description – Quality Assurance Executive / Senior Executive

Department: Quality Assurance
Experience: 3–7 years in Medical Device
Employment Type: Full time
Reporting To: CEO
Location: Gandhinagar, Gujarat

Job Summary
We are looking for a competent and self-driven Quality Assurance professional with 3–7 years of experience in medical device and sterilization, surgical instruments and higher risk devices. The candidate should be capable of handling internal and external audits, routine QA activities, quality documentation, compliance monitoring, and coordination with cross-functional departments. The candidate will also act as the Management Representative (MR) and coordinate QMS implementation, maintenance, performance reporting, management reviews, and continual-improvement activities.

Key Responsibilities
• Plan, conduct, and document internal quality audits.
• Coordinate and support customer, certification-body, supplier, and regulatory audits.
• Prepare audit schedules, checklists, reports, observations, and compliance records.




• Follow up on audit findings and ensure timely closure of corrective and preventive actions.
• Handle routine QA activities and ensure adherence to approved procedures.
• Manage deviations, non-conformances, CAPA, change controls, and related investigations.
• Perform root-cause analysis and recommend effective corrective and preventive measures.
• Prepare, review, revise, issue, and control SOPs, work instructions, formats, specifications, and quality records.
• Ensure effective document control, including version control, distribution, retrieval, archival, and disposal of obsolete documents.
• Monitor compliance with the Quality Management System and applicable statutory, regulatory, and customer requirements.
• Review batch, process, inspection, testing, or production records, as applicable.
• Coordinate with Production, Engineering, Purchase, Stores, QC, and other departments to resolve quality-related issues.
• Support suppl

📌 Senior Executive Quality Assurance (Gandhinagar)
🏢 Shira MedTech
📍 Gandhinagar