Quality Assurance Executive, Vapi

Job Title: QA Executive– Surgical Robotics. Department: Quality Assurance – Surgical Robotics Division. Location: Vapi, Gujarat. Reports To: Manager / Senior Manager – Quality Assurance. Job Purpose: To support the Quality Assurance system for surgical robotic products by ensuring compliance with ISO 13485, internal SOPs, and regulatory requirements through documentation control, process adherence, non-conformance handling, and coordination with cross-functional teams.Key Responsibilities: 1. Quality System&Compliance Support• Support implementation and maintenance of the Quality Management System (QMS) in line with ISO 13485 requirements. • Ensure adherence to quality procedures, work instructions, and regulatory standards across manufacturing and inspection activities. • Promote quality awareness and compliance culture across departments.2. Documentation&Records Management• Maintain and control quality-related documents and records in compliance with Good Documentation Practices (GDP). • Support preparation, review, and archival of quality documents such as SOPs, formats, logs, and reports. • Ensure document traceability, version control, and audit readiness.3. Inspection&Quality Oversight• Support incoming, in-process, and final inspection activities from a QA oversight perspective. • Review inspection records and ensure compliance with engineering drawings and quality requirements. • Coordinate with QC teams for raw material inspection planning and execution.4. Non-Conformance&Deviation Handling• Assist in documentation and tracking of Non-Conformance Reports (NCRs) and deviations. • Support root cause analysis and follow-up of corrective and preventive actions (CAPA) under supervision. • Ensure timely closure and proper documentation of quality issues. 5. Cross-Functional Coordination• Coordinate with Quality Control, Manufacturing, Engineering, and R&D teams to ensure quality requirements are met.• Support internal audits, inspections, and quality reviews. • Assist in continuous improvement initiatives related to quality processes and documentation. Qualifications and Experience: • Degree in Mechanical/Electrical/ Electronic Engineering (or relevant engineering discipline).• 1–3 years of experience in Quality Assurance or Quality Control within medical devices, surgical instruments, surgical robotics, or regulated manufacturing environments. • Exposure to medical device quality systems is preferred. Skills and Competencies: • Basic understanding of qualitycontrol principles and inspection processes.• Strong attention to detail, observation, and analytical skills. • Ability to read and interpret engineering drawings. • Familiarity with inspection tools such as vernier callipers, micrometres, gauges, and measuring instruments. • Basic awareness of ISO 13485 – Medical Device QMS. •Understanding of Good Documentation Practices (GDP).• Basic knowledge of NCRs, deviations, and CAPA concepts. • Proficiency in MS Office (Word, Excel, PowerPoint). • Good communication skills, teamwork, and disciplined working approach. • Willingness to learn and grow in a regulated global MedTech environment. Key Performance Indicators (KPIs):• Accuracy and completeness of QA documentation • Compliance with ISO 13485 and internal SOPs • Timely tracking and closure of NCRs and deviations • Audit readiness and documentation accuracy • Effective coordination with QC and cross-functional teams