Department: Quality Assurance and Regulatory Affairs
Reports to: QARA Manager
Experience: 3–5 years in medical device hardware / electronics manufacturing
Location: Hybrid (Malleswaram, Bangalore)
Qualification: Bachelor's in Electronics, Biomedical, or related Engineering discipline

Role Overview
The QC Engineer – Hardware is responsible for incoming, in-process, and final quality checks
on hardware products, ensuring devices meet approved specifications before release. This is
a hands-on floor role working closely with Production, R&D;, and QA/RA to maintain product
quality and compliance with ISO 13485:2016.

Key Responsibilities
• Conduct incoming inspection (IQC), in-process (IPQC), and final quality checks (FQC)
on components and finished hardware products.
• Perform functional testing on devices such as ECG and ECHO machines.
• Review and maintain inspection records, test reports, and batch documentation
(DHR support).
• Identify and log non-conformances; support root cause analysis and corrective
actions (CAPA).




• Coordinate with Production and R&D; to resolve quality issues on the shopfloor.
• Support internal audits and ensure QC processes align with ISO 13485:2016.
• Maintain calibration schedules and records for test/measuring equipment, ensuring
traceability.
• Develop and update inspection plans, checklists, and acceptance criteria for new and
existing products.
• Support qualification of new components/vendors.
• Perform failure analysis on returned/defective units and coordinate with R&D; on
design-related issues.
• Maintain and control QC-related documentation, including SOPs, WIs, and test
protocols.
• Ensure proper segregation, labelling, and handling of accepted/rejected material.
• Support supplier quality evaluation and incoming material audits.
• Assist in validation activities (IQ/OQ/PQ) for manufacturing and test equipment.

What We're Looking For
• Valuable to have: hands-on experience with ECG and/or ECHO machines
• Familiarity with ISO 13485:20

📌 QC Engineer (Bengaluru)
🏢 Tricog Health
📍 Bengaluru