Job Location:
Lucknow

Department:
Quality Control

Reports to:
Director

Job Description

The QC Manager (Electro-Medical Devices) is responsible for leading the quality control operations, ensuring all electronic components, sub-assemblies, and finished medical devices meet technical specifications, safety standards, and regulatory requirements (EN ISO 13485, IEC 60601, IS/IEC 80601-02, IS 13450, IS 11378, FDA). This role directly impacts patient safety through rigorous technical testing, root cause analysis, and final product release.

Key Responsibilities

1. Technical Quality Operations & Inspection (Electrical Focus)
- Oversee incoming inspection of electronic components (PCBs, sensors, motors, cables) and raw materials.
- Manage in-process and final inspection, including safety testing (insulation resistance, Hi-pot, leakage current, dielectric strength, earth continuity) for electrical medical devices.
- Validate test methods to ensure accuracy of electrical measurements and functional tests.
- Ensure compliance with ISO 13485, IEC 60601, IS/IEC 80601-02, IS 13450, IS 11378,



FDA standards for medical electrical equipment safety.

2. Regulatory Compliance & Documentation
- Maintain the Quality Management System (QMS) in compliance with
ISO 13485:2016, I MDR 2017, FDA 21 CFR Part 820
, and
EU MDR 2017/745
- Review and approve Device History Records (DHR), Test Reports, and Batch Records for product release.

3. CAPA & Failure Investigation
- Lead Root Cause Analysis (RCA) for non-conforming electronic components, using techniques like 5 Whys, Fishbone, and FMEA.
- Manage Corrective and Preventive Actions (CAPA) to closure.
- Investigate customer complaints related to electrical malfunctions, implementing corrective measures.

4. Team Leadership & Supplier Quality
- Supervise and train QC technicians and engineers on electrical testing protocols and equipment usage.
- Perform supplier audits and quality evaluations for electronic components.
- Oversee calibrati

📌 Senior Quality Control Manager (Lucknow)
🏢 Heidelco Medicore Private
📍 Lucknow