Roles and 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 Required Skills Strong knowledge of ISO 13485 ISO 9001 ISO 14971 and Indian MDR 2017 Hands-on experience with quality data analysis metrics tracking and report generation Competence in Nonconformance handling CAPA management and Root Cause Analysis tools Robust skills in Document Control SOPs Work Instructions Records and version management Familiarity with Internal Audits and Audit preparedness ISO Regulatory Customer Audits Experience in Engineering Change Management ECR ECO process Awareness of medical device safety standards IEC 60601-1 IEC 60601-1-2 etc Strong analytical and problem-solving skills for quality investigations High attention to detail and accuracy Effective communication and interpersonal skills Strong time management and organizational skills Adaptability and ability to work effectively with cross-functional teams R D Production Procurement Skilled in report writing and presentation Qualifications B Tech in Biomedical Electronics Electrical related field Experience 1 - 3 Years Job Location Thiruvananthapuram Job Type Full-time

📌 Qa/ra Enineer (Kerala)
🏢 Recognized
📍 Kerala