Medical Device Engineer jobs

Quality Management System (QMS)

• Implement, maintain, and continuously improve the Quality Management System (QMS) in line with ISO standards (ISO 9001 / ISO 13485).

NABL Compliance & Accreditation

• Ensure compliance with NABL guidelines (ISO/IEC 17025 / ISO 15189 as applicable).
• Prepare and maintain documentation required for NABL accreditation and audits.
• Coordinate with technical teams to ensure calibration, validation, and testing procedures meet NABL standards.
• Handle NABL audits (internal & external) and ensure timely closure of non-conformities (NCs).

Internal & External Audits

• Plan and conduct internal audits across sites and projects.
• Coordinate external audits (ISO/NABL/Client audits).
• Prepare audit reports and ensure corrective and preventive actions (CAPA).

Documentation & Compliance

• Maintain quality records, calibration records, service reports, and compliance registers.
• Ensure proper documentation for biomedical equipment maintenance logs.
• Control document revisions and versioning as per ISO requirements.

Process Improvement

• Identify gaps in service quality and implement process improvements.
• Drive CAPA (Corrective and Preventive Actions) initiatives.
• Monitor KPIs related to service quality, turnaround time, and customer satisfaction.

Regulatory & Safety Compliance

• Ensure compliance with biomedical equipment safety standards and regulatory requirements.
• Coordinate with hospitals/government bodies for quality compliance under AMC/CMC projects.
• Ensure documentation, control, and compliance of SOPs, policies, and procedures.
• Monitor adherence to quality standards across all service and maintenance activities.

Job Type: Full-time

Pay: ₹50,000.00 - ₹60,000.00 per month

Education:

• Bachelor's (Preferred)

Experience:

• total work: 1 year (Preferred)

Work Location: In person