Job Description

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 recent 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

• Good to have: hands-on experience with ECG and/o

📌 QC Engineer (Bengaluru)
🏢 Tricog Health
📍 Bengaluru