Assistant Quality Engineer

Job Description

Job Title: Assistant Quality Manager / Quality Engineer Experience: 2–5 Years Department: Quality Assurance / Quality Control Industry: Medical Devices / Pharma / Healthcare Standards: ISO 13485, QMS, Regulatory Compliance Job Responsibilities: Assist the Quality Manager in maintaining and improving the Quality Management System (QMS) as per ISO 13485 requirements. Prepare and update Standard Operating Procedures (SOPs), Work Instructions, and Quality Manual. Participate in internal audits , supplier audits, and external regulatory audits (e.g., ISO, FDA). Support CAPA (Corrective and Preventive Action) and non-conformance investigations. Monitor and ensure document control , calibration, validation, and traceability of processes and equipment. Conduct training and awareness programs on QMS and regulatory requirements. Assist in product quality inspections and manage deviations and change controls. Maintain risk management files as per ISO 14971 (if applicable). Coordinate with cross-functional teams (R&D, production, supply chain) to ensure compliance. Prepare and maintain quality reports, metrics, and audit findings. Key Skills Required: Strong understanding of ISO 13485 QMS principles. Knowledge of GMP, CAPA, NCR, RCA, Validation, Risk Management . Proficient in internal audit processes and documentation practices. Attention to detail and analytical thinking. Excellent communication and organizational skills. Job Type: Full-time Pay: ₹30,000.00 - ₹40,000.00 per month Benefits: Health insurance Provident Fund Schedule: Day shift Work Location: In person