Manager/Senior Manager : Quality Control (Electro-Medical Devices)

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 calibration of electrical measuring instruments and test equipment.

Required Skills and Qualifications

• Education: Bachelor’s or master’s degree in Electrical Engineering, Biomedical Engineering, or Electronics Engineering.
• Experience: 8–10 years of experience in Quality Control, with at least 5 years in a technical leadership role within the medical device industry.
• Technical Knowledge:
• In-depth knowledge of IEC 60601, IS/IEC 80601-02, IS 13450, IS 11378 (safety) and IEC 60601-1-2 (EMC).
• Hands-on experience with multimeters, function generators, and automated test equipment (ATE).

Location- Transport Nagar, Lucknow