Quality Control Executive

2 days ago

Andheri Mumbai Maharashtra, India MakeO Toothsi Full time

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
- Conduct incoming, in-process, and final product inspections as per approved SOPs and quality plans. - Perform testing and analysis using QC instruments and ensure calibration/maintenance of equipment. - Review and maintain test reports, inspection records, and control charts for compliance with ISO 13485 and regulatory standards. - Assist in root cause analysis for non-conformances and support corrective and preventive actions (CAPA). - Collaborate with Production, QA, and R&D teams to ensure product quality and resolve issues promptly. - Participate in internal audits, supplier evaluations, and regulatory inspections. - Ensure proper handling, labelling, and storage of materials as per quality guidelines.

**Qualifications**:

- Bachelor’s degree in Science (Chemistry, Biology), Engineering, or related field. - 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. - Strong documentation and report-writing skills. - 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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