09 Aug
|
Tricog Health
|
Bengaluru
09 Aug
Tricog Health
Bengaluru
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
- 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
- Solid attention to detail and hardware troubleshooting skills
- Good communicator, able to coordinate across teams
📌 QC Engineer (Bengaluru)
🏢 Tricog Health
📍 Bengaluru