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Qa officer

2 months ago

Navi Mumbai, India IF MedTech Pvt Ltd Full time

At IF Med Tech, we are dedicated to revolutionising healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives. Join us in our mission to drive innovation and make a global impact in the medical technology sector. Responsibilities Role and responsibility as QA - Quality Assurance Officer Establishing, verifying and maintaining Software Quality Management System (QMS). Develop and implement the Quality Management System (QMS) in line with ISO 13485, IMDR, 2017 and FDA QSR. Create and maintain quality manuals, procedures, and work instructions. Ensure the QMS covers all aspects of product development, manufacturing, and post-market activities. Preparing Design History File Other activities related to QMS: Plan and conduct internal audits to verify QMS compliance with regulatory standards (ISO 13485, FDA, IMDR). Prepare for external audits (e.g., by Notified Bodies, FDA, CDSCO). Manage supplier non-conformances and work with them to resolve issues in a timely manner. Manage post-market surveillance activities to monitor product performance and safety once the product is on the market. Report adverse events to regulatory authorities as required (e.g., MDR, Vigilance Reporting). Develop and conduct training programs for employees on quality assurance procedures, regulatory requirements, and compliance standards. Qualifications 3-5 years of experience in QA roles in the medical device industry. Knowledge of ISO 13485, IMDR 2017, FDA QSR, EU MDR/IVDR and other global regulatory requirements. Excellent understanding of product development lifecycle in the medical device industry. Certified internal auditor as per ISO 13485 Demonstrated problem-solving abilities and a proactive approach to regulatory and technical challenges. Strong interpersonal skills and the ability to work effectively in a collaborative, multidisciplinary team environment. Commitment to quality, safety and compliance in all aspects of work. Strong attention to detail and analytical skills. Joining within 10 days