Role & responsibilities
Job Description Quality Controller
Work Mode:
Production Areas
Location:
Ambattur, Chennai
Experience:
Min 3 years in relevant exp
Roles & Responsibilities
- Inspect raw materials, components, and subassemblies per SOPs, Drawings, Control Plans, and master record requirements.
- Perform visual, dimensional, and functional tests using calibrated instruments and coordinate Microscope / Vision where applicable.
- Apply sampling plans; quarantine non-conformance material; raise NCRs with evidence (photos/measurements).
- Maintain inspection records, inprocess check sheets, final release documentation, and CoA/CoC verification.
- Ensure complete product records; verify master records versions, change control, and label accuracy.
- Log NCRs with containment; perform preliminary RCA (5Why, Fishbone); collaborate for correction & CAPA.
- Adhere to ISO 13485 QMS procedures, and applicable EU MDR requirements as per site QMS.
- Follow GMP/GDP, EHS, cleanroom gowning/behavior; ensure calibration control per ISO 10012/MSA.
- Drawing reading with basic GD&T; proficiency with gauges and measurement methods.
- Knowledge of ISO 13485, understanding of product and process records, label controls, document control.
- Exposure to MSA (GR&R awareness), Control Plans; cleanroom/ESD familiarity.
- Gauges/Equipment: Vernier, micrometers, height gauge, bore gauge, surface plate, profile projector/vision system, thread/plug/ring gauges, torque wrench, hardness/roughness testers; Microscope/Xray (as applicable).
- Software & QMS: MS Office, QMS.
- Documents: Drawings/specs, SOPs, Control Plans, calibration records, non-conformance logs, product records, labeling.