Quality Assurance Specialist

5 days ago

Ahmedabad India HOPS HEALTHCARE Full time

Job Description Company Overview KALI Medtech Pvt Ltd. (OOM) is an upgrowing company within Hops innovating various healthcare products thereby expanding horizons in telehealth & remote patient monitoring. We are a team of self-driven young individuals, focusing on making healthcare easier, smarter & less tedious. At KALI, we ensure that our users are comfortable & satisfied with our products. Our team works cooperatively to revolutionize digital health systems. Role Overview We are seeking a Quality Assurance (QMS) professional who will play a key role in maintaining and improving our Quality Management System in compliance with ISO 13485:2016 and 21 CFR Part 820. The role involves active participation in audits, CAPA, risk management, supplier control, and document management processes to ensure the highest quality standards across product development and manufacturing. Key Responsibilities: Implement, maintain, and improve the Quality Management System (QMS) in accordance with ISO 13485 and FDA 21 CFR Part 820. Participate in internal audits, supplier audits, and management reviews. Maintain control of QMS documentation including SOPs, Work Instructions, Forms, and Records. Manage nonconformities (NC), Corrective and Preventive Actions (CAPA), and complaint handling processes. Coordinate quality inspections for incoming, in-process, and finished goods to ensure product conformity. Support validation activities (IQ/OQ/PQ), calibration, and preventive maintenance documentation. Review Device History Records (DHR), Device Master Records (DMR), and other production quality documents. Ensure traceability of components and maintain batch records. Assist in training programs to improve quality awareness and compliance culture. Liaise with cross-functional teams (Production, R&D, Regulatory, etc.) to resolve quality issues. Support external certification and surveillance audits by Notified Bodies or regulatory agencies. Qualification & Skills: Bachelor's degree in Biomedical, Electronics, or related Engineering / Life Sciences field. Knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and GMP principles. Strong analytical, documentation, and problem-solving skills. Good communication and interpersonal skills. Ability to manage multiple tasks and meet deadlines in a fast-paced environment. Prior experience or internship in a medical device manufacturing or QA/QC environment will be an added advantage. Interested candidates can apply on [Confidential Information]

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