Quality Assurance Executive

6 days ago

Imphal MN IN St. Stone Medical Devices Privted Limited Full time

- QA QC Executive Pharma Medical Devices Industry Position QA QC Executive Department Quality Assurance Quality Control Location A-8 KURAOPOKDI INDUSTRIAL ESTATE THOUBAL KAKCHING IMPHAL MANIPUR INDIA 795135 Experience 1-3 Years Medical Devices Pharma Preferred Qualification B Sc M Sc B Pharm M Pharm or relevant discipline Key Responsibilities Quality Assurance Responsibilities Support implementation and maintenance of Quality Management System QMS as per ISO 13485 standards QA-QC PROFILE Manage documentation - SOPs Quality Plans BMR review DMR Device Master File preparation etc QA-QC PROFILE Conduct and participate in Internal Audits and assist during external audits Perform incoming in-process and final product inspections Assist in Management Review Meetings with required data and reports Provide training related to QMS and maintain related documentation Quality Control Responsibilities Testing of Raw Materials In-process and Finished Products QA-QC PROFILE Perform Microbiological testing Sterility Testing Bacterial Endotoxin Testing Bioburden and Sub-culturing activities Physicochemical testing QA-QC PROFILE Operation handling and calibration of laboratory equipment Ensure environmental control and monitoring in controlled areas Support audits and compliance activities in QC laboratory Skills Competencies Good understanding of ISO 13485 and regulatory requirements Strong knowledge in product quality inspection methods incoming in-process PDI FDI Ability to implement and maintain documentation as per standards Detail-oriented with strong analytical and problem-solving skills Team player with effective communication skills The person must have experience in medical devices manufacturing industries in QA RA department Job Types Full-time Permanent Pay 25 000 00 - 35 000 00 per month Education Bachelor s Preferred Experience total work 1 year Required Work Location In person

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