QA/RA Engineer

We are seeking a motivated QA/RA Engineer to support the implementation, maintenance, and improvement of our Quality Management System (QMS) in compliance with global standards and regulations (ISO 9001, ISO 13485, IEC 62304, MDR). In this role, you will collaborate with cross-functional teams to manage documentation, assist in audits, support regulatory submissions, and promote a strong culture of quality across the organization. This position is ideal for candidates with 1 3 years of experience in quality assurance and regulatory affairs who are looking to expand their expertise and grow into a key contributor to compliance and business success. Key Responsibilities Support in implementing, maintaining, and improving the QMS as per ISO 13485, ISO 9001, Indian MDR 2017, applicable standards and regulatory requirements. Manage and control documents including version control and distribution. Support in Engineering Change management (ECR/ECO process) and ensure compliance to procedures Record, investigate, and track Nonconformances (NCs) raised across departments. Support Root Cause Analysis and CAPA processes. Follow up with responsible teams to ensure timely closure of actions and effectiveness verification Prepare, coordinate, and support internal audits and external audits (ISO certification, regulatory audits, customer audits). Assist in maintaining audit readiness and ensure compliance with requirements. Provide assistance in preparing and maintaining technical documentation for regulatory submissions. Stay updated on changes in standards and regulatory requirements applicable to company products Collect, analyze, and present quality performance data (NC trends, CAPA status, audit findings). Prepare reports for Management Review Meetings (MRM) and support decision-making through data insights Assist in planning and conducting QMS trainings for employees on SOPs, CAPA, NC handling, and regulatory compliance. Promote a quality culture across teams through regular engagement and awareness sessions Work closely with R D, Production, and Procurement to ensure compliance throughout the product lifecycle. Participate in design reviews, risk management activities (ISO 14971), and process improvements