Need Quality Assurance Manager who leads

- Quality Management System (QMS)

- Establish and maintain Quality Management System.
- Implement ISO 13485, ISO 9001, GMP, and CDSCO requirements.
- Prepare and control SOPs, work instructions, and quality manuals.
- Ensure document control and record retention.

2. Raw Material Quality Control
- Approve incoming raw materials such as:
- Natural Latex
- Nitrile Latex
- Chemicals and Additives
- Packing Materials
- Verify Certificates of Analysis (COA).
- Monitor supplier quality performance.

3. In-process Quality Monitoring
- Monitor glove manufacturing processes:
- Latex compounding
- Dipping process
- Vulcanization
- Chlorination/Polymer Coating
- Drying and stripping
- Ensure process parameters remain within specification.
- Minimize defects and rejection rates.

4. Finished Product Testing

Ensure compliance with standards such as:

- ASTM D5151 (Freedom from Holes)
- ASTM D412 (Tensile Strength)
- ISO 11193
- EN 455
- ASTM D6319 (Nitrile Gloves)

Typical tests:
- AQL testing
- Water leak test
- Tensile strength
- Elongation
- Dimension checks
- Thickness measurement
- Visual inspection [VQ Format...cellenious | PDF], [maxter-3-0...nical-file | PDF]

5. Product Release & Batch Approval
- Review batch manufacturing records.
- Verify all test results.
- Release finished goods for dispatch.
- Reject non-conforming batches.

6. Handling Customer Complaints
- Investigate quality complaints.
- Conduct Root Cause Analysis (RCA).
- Implement Corrective and Preventive Actions (CAPA).
- Submit investigation reports within defined timelines.

7. Regulatory Compliance

Ensure compliance with





- CDSCO requirements
- ISO 13485
- CE requirements
- FDA requirements (if exported to USA)
- Medical device regulations

8. Internal and External Audits
- Conduct internal quality audits.
- Coordinate customer audits.
- Face regulatory inspections.
- Close audit observations through CAPA.

9. Non-Conformance & OOS Management
- Handle Out-of-Specification (OOS) results.
- Investigate process deviations.
- Maintain Non-Conformance Reports (NCR).
- Prevent recurrence of defects.

10. Training and Competency Development
- Train QA, QC, Production, and Packing personnel.
- Conduct GMP and Hygiene training.
- Evaluate employee competency periodically.

11. Change Control Management
- Assess impact of:
- New raw materials
- New suppliers
- Process changes
- Equipment modifications
- Approve changes only after validation.

12. Validation Activities
- Process Validation
- Cleaning Validation
- Equipment Qualification
- Packaging Validation
- Shelf-life Studies

13. Supplier Qualification
- Evaluate and approve suppliers.
- Conduct supplier audits.
- Maintain approved vendor list.
- Monitor supplier performance.

14. Data Analysis and Reporting

Prepare monthly quality reports covering:

- Rejection percentage
- Customer complaints
- AQL failure rate
- CAPA status
- Audit findings
- Supplier quality performance

15. Continuous Improvement
- Reduce manufacturing defects.
- Improve First Pass Yield (FPY).
- Implement Lean and Six Sigma initiatives.
- Optimize quality costs.

Pay: Up to ₹45,000.00 per month

Benefits

- Adaptable schedule

Work Location: In person

📌 Quality Assurance Executive (Visakhapatnam)
🏢 EGIS GLOVES PRIVATE
📍 Visakhapatnam