Shiva Gajula

Hands-on experience in FMCG, Medical Device, Electrical, and Oral Care manufacturing industries. Experienced in handling Coordinate Measuring Machine (CMM) for dimensional inspection and verification activities. Strong knowledge of engineering drawings, GD&T, dimensional tolerances, and quality inspection standards. Hands-on experience in FAI, performance testing, assembly inspection, and process validation activities.

Experience in handling injection molds ranging from 1 to 96 cavities including Flip Top Caps and CRC Caps. Worked on New Product Development (NPD), mold trials, validation, and continuous improvement activities. Knowledge of ISO 13485, GMP documentation practices, and Quality Management System (QMS) requirements.

Experience in audit support activities including internal audits, customer audits, and documentation review. Hands-on experience in CAPA (Corrective and Preventive Action), root cause analysis, deviation handling, and non-conformance reporting. Experienced in preparation and maintenance of SOPs, DHR, DMF, batch records, and controlled quality documents.

Ensured documentation control, traceability, GMP compliance, and adherence to quality procedures and regulatory standards. Good understanding of medical device quality systems, validation activities, and compliance requirements. Strong analytical, troubleshooting, and problem-solving skills with focus on product quality and manufacturing efficiency.

Quality Engineer – CMM & Plastic Division - ELITE PRECISION TECHNOLOGIES PVT LTD.

(2022-07)

Graduate Trainee – Quality Division (CMM) - AMRITHA TOOL CRAFTS PVT LTD. (UNIT-II)

(2015-07 - 2022-07)

B.Tech - Mechanical Engineering - Kamala Institute of Technology & Science, Karimnagar (2019)

SSC - Wisdom High School, Warangal (2013)