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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