Key Responsibilities:
Conduct quality inspections and testing of raw materials, in-process products, and finished medical devices.
Monitor product quality to ensure compliance with approved specifications and applicable standards.
Perform dimensional, visual, functional, and other quality checks on medical devices, including disposable syringes, needles, and IV infusion sets.
Maintain quality control records, inspection reports, test reports, and batch-wise documentation.
Assist in implementing and maintaining the Quality Management System (QMS).
Ensure compliance with applicable ISO standards, BIS requirements, and Medical Device Rules, 2017, as relevant to the products.
Identify quality issues, investigate non-conformities, and support corrective and preventive actions (CAPA).
Coordinate with production, quality assurance, regulatory, and other departments to resolve quality-related issues.
Monitor calibration and maintenance records of inspection and testing equipment.
Support internal and external audits, inspections, and regulatory assessments.
Ensure proper handling, storage,



identification, and traceability of raw materials and finished products.
Assist in preparing SOPs, work instructions, quality manuals, and other technical documentation.
Ensure compliance with hygiene, safety, and documentation practices in the manufacturing facility.

Requirements:
B.Tech / B.E. in Mechanical, Biomedical, or a related engineering discipline; a relevant science qualification may also be considered depending on the role requirements.
04 years of experience in quality control, preferably in medical devices, medical disposables, or pharmaceutical manufacturing.
Knowledge of ISO 13485, ISO 9001, and applicable medical device quality requirements.
Familiarity with inspection methods, testing procedures, sampling techniques, and quality documentation.
Basic knowledge of MS Excel, MS Word, and preparation of quality reports.
Robust analytical, problem-solving, and documentation skills.

📌 Quality Control Engineer Patna
🏢 Maruti Meditech
📍 Patna