Quality Assurance Specialist (QMS)

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:

• Bachelors 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 [HIDDEN TEXT]