Role Summary
Responsible for ensuring that all raw materials, in-process, and finished products meet quality and regulatory requirements. The role involves inspection, testing, documentation, and supporting continuous improvement in the QC processes for medical device manufacturing.
Key Responsibilities o
Conduct incoming, in-process, and final product inspections as per approved SOPs and quality plans. o Perform testing and analysis using QC instruments and ensure calibration/maintenance of equipment. o Review and maintain test reports, inspection records, and control charts for compliance with ISO 13485 and regulatory standards. o Assist in root cause analysis for non-conformances and support corrective and preventive actions (CAPA). o Collaborate with Production, QA, and R&D teams to ensure product quality and resolve issues promptly. o Participate in internal audits, supplier evaluations, and regulatory inspections. o Ensure proper handling, labelling, and storage of materials as per quality guidelines.
Qualifications
Bachelor's degree in Science (Chemistry, Biology), Engineering, or related field. o Knowledge of medical device quality systems (ISO 13485, GMP) is preferred.
Experience
1-3 years of experience in QC within medical devices, pharma, or similar regulated industry.
Skills Required
Good understanding of testing methods, measuring instruments, and data analysis. o Strong documentation and report-writing skills. o Knowledge of regulatory requirements (ISO, CDSCO, FDA) will be an advantage.
Job Types: Full-time, Permanent, Fresher
Pay: ?250,000.00 - ?350,000.00 per year
Benefits:
Cell phone reimbursement
Health insurance
Provident Fund
Work Location: In person
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