Department: Quality Assurance and Regulatory AffairsReports to: QARA ManagerExperience: 3–5 years in medical device hardware / electronics manufacturingLocation: Hybrid (Malleswaram, Bangalore)Qualification: Bachelor's in Electronics, Biomedical, or related Engineering disciplineRole OverviewThe QC Engineer – Hardware is responsible for incoming, in-process, and final quality checkson hardware products, ensuring devices meet approved specifications before release. This isa hands-on floor role working closely with Production, R&D;, and QA/RA to maintain productquality 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 correctiveactions (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, ensuringtraceability.
- Develop and update inspection plans, checklists, and acceptance criteria for new andexisting products.
- Support qualification of recent components/vendors.
- Perform failure analysis on returned/defective units and coordinate with R&D; ondesign-related issues.
- Maintain and control QC-related documentation, including SOPs, WIs, and testprotocols.
- 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/or ECHO machines
- Familiarity with ISO 13485:2016 quality processes
- Working knowledge of electronic test equipment
- Strong attention to detail and hardware troubleshooting skills
- Good communicator, able to coordinate across teams
📌 Qc Engineer (Bengaluru)
🏢 Tricog Health
📍 Bengaluru
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