Job Description

Primary role :- The Internal Auditor is responsible for evaluating the effectiveness of internal controls, processes, and systems to ensure compliance with applicable regulatory, quality, and company requirements. This role is critical in maintaining a compliant and efficient Quality Management System (QMS) in accordance with standards such as ISO 13485, CDSCO -13485 , CE , BIS, (QSR), and other applicable global regulations for medical devices.

Develop and maintain an internal audit schedule based on risk assessment and regulatory requirements.

Plan, prepare, and conduct internal audits of manufacturing, assembly, quality, and support processes.

Conduct process, product, and system audits in various departments: production, engineering, store, Warehouse, calibration, and validation.

BIS

:- Submitted and maintained product registrations with BIS.

CDSCO :-

Submitted and maintained product registrations with CDSCO.

ISO

:- 13485ISO 13485 (Medical Devices - Quality Management Systems), Prepare all the relevant documents and records.

Developed SOPs, per ISO 13485 and regulatory requirements.

Risk & CAPA :- Root Cause Analysis, Complaint Handling, PMS, Change controls, Deviations, NC, OOS (Out of Specification), CAPA, FSCA ( Field Safety Corrective Action).

Analyzed customer complaints, deviations, and trends to implement effective CAPA.

3.) Investigated NCs and customer complaints using CAPA and root cause analysis tools.

Software installation in various machine & equipment's Like :- Monitor, ECG, Pulse OXI Meter etc.

Core Responsibilities:-

1.) ISO 13485, CDSCO, CE, BIS. 2.) LEAN and Six Sigma principles (for process improvement audits) 3.) QMS Documentation : Technical File, DMF, RMF. 4.) Managed QMS documentation and change control processes from development to launch.

Job Type: Full-time

Pay: ₹20,000.00 - ₹40,000.00 per month

Benefits:

Cell phone reimbursement Food provided Provident Fund
Work Location: In person