Associate– Production- Electropolishing

1 day ago

Tiruchirappalli, India Concept Medical Full time

Job Purpose To carry out electropolishing operations for medical device components in compliance with approved procedures, quality standards, and ISO 13485 requirements, while ensuring safe handling of chemicals, accurate documentation, and smooth coordination with cross-functional teams. Key Responsibilities • Perform electropolishing solution preparation and execute BMS electropolishing operations as per approved work instructions. • Ensure equipment calibration, QA line clearance, and strict adherence to ISO 13485:2016 and internal QMS requirements. • Represent the Production Department during internal, customer, and external regulatory audits. • Maintain and update QMS documentation, including change controls, deviations, CAPA, and related production records. • Monitor and manage chemical consumption, maintain inventory, and ensure safe storage and disposal of waste chemicals in compliance with EHS norms. • Verify product labelling, batch details (cell number, size, lot number), and ensure accurate transfer of Batch Manufacturing Records (BMRs) to subsequent processes. • Perform SAP transactions, including production order processing, ITR entries, material issue, and material receipt. • Prepare purchase requisitions for consumables and chemicals required for production activities. • Submit daily production status reports and updates to the Production Manager. • Follow Good Manufacturing Practices (GMP), safety guidelines, and company policies at all times. • Support continuous improvement initiatives to enhance process efficiency and product quality. Qualifications & Experience • Education: Diploma / bachelor’s degree in Chemistry ,chemical, Mechanical, Biomedical, or related engineering discipline. • Experience: o 2–5 years of experience in electropolishing or surface treatment operations, preferably in a medical device or regulated manufacturing environment. o Hands-on experience with ISO 13485, QMS documentation, and audit support.

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