Quality Assurance Specialist | Medical Devices | Remote

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. Our team works cooperatively to revolutionize digital health systems.

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
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
Implement, maintain, and improve the Quality Management System (QMS) in accordance
Maintain control of QMS documentation including SOPs, Work Instructions, Forms, and
Manage nonconformities (NC), Corrective and Preventive Actions (CAPA), and complaint
Coordinate quality inspections for incoming, in-process, and finished goods to ensure product
production quality documents.

• Assist in training programs to improve quality awareness and compliance culture.
• Liaise with cross-functional teams (Production, R&D, Regulatory, etc.) to resolve quality

Support external certification and surveillance audits by Notified Bodies or regulatory
Bachelor's degree in Biomedical, Electronics, or related Engineering / Life Sciences field.
• Prior experience or internship in a medical device manufacturing or QA/QC environment will