Assistant Manager – Quality Assurance

Job Title: Assistant Manager – Quality Assurance. Department: Quality Assurance – Surgical Robotics Division. Location: Vapi, Gujarat. Reports To: Manager – Quality Assurance / Head – Quality. Job Purpose: To lead and strengthen the Quality Assurance function for surgical robotic products by ensuring effective implementation of the ISO 13485 Quality Management System, regulatory compliance, robust documentation practices, and proactive quality risk management across manufacturing, inspection, and testing processes. Key Responsibilities: • Develop and implement a comprehensive quality plan to ensure compliance with regulatory requirements and industry best practices. • Lead and manage a team of quality engineers and inspectors to ensure effective implementation of the ISO 13485 Quality Management System. • Conduct regular audits and assessments to identify areas for improvement and implement corrective actions. • Collaborate with cross-functional teams to resolve quality-related issues and implement process improvements. • Develop and maintain quality procedures, work instructions, and training programs to ensure compliance with regulatory requirements and industry best practices. • Ensure that all quality-related documentation is accurate, complete, and up-to-date. • Identify and mitigate quality risks through proactive risk management and continuous improvement initiatives. • Develop and track key performance indicators (KPIs) to measure the effectiveness of the Quality Assurance function. • Collaborate with other departments to ensure effective implementation of quality-related processes and procedures. • Ensure that all quality-related activities are properly documented, recorded, and reported. Job Requirements: • Bachelor's degree in Engineering, Technology, or a related field. • Minimum 5 years of experience in quality assurance, engineering, or a related field. • Strong understanding of ISO 13485 Quality Management System and regulatory requirements. • Excellent leadership, communication, and interpersonal skills. • Ability to work effectively in a fast-paced environment with multiple priorities and deadlines. • Strong analytical and problem-solving skills. • Ability to travel up to 10% of the time. Benefits: • Competitive salary package. • Comprehensive health insurance. • Retirement plan. • Paid time off. • Professional development opportunities.