Quality Supervisor
Department
Quality Assurance & Quality Control
Reporting To
Plant Head
Location
Imphal, Manipur
Industry
Medical Device Manufacturing
Job Purpose
We are seeking a proactive and detail-oriented Quality Supervisor to oversee day-to-day quality activities in the manufacturing plant. The role involves monitoring production quality, supervising inspection activities, ensuring compliance with quality standards, investigating quality issues, and supporting continuous improvement initiatives.
The ideal candidate should have experience in Medical Device Manufacturing, Quality Control, Process Inspection, Documentation, and Regulatory Compliance.
Key ResponsibilitiesProduction Quality Monitoring
- Monitor in-process and final product quality during manufacturing.
- Ensure compliance with approved specifications, SOPs, and work instructions.
- Conduct routine shop-floor quality inspections.
- Verify line clearance and process compliance before production activities.
Inspection & Testing
- Supervise incoming, in-process, and final inspection activities.
- Ensure proper sampling, testing, and documentation of quality records.
- Review inspection reports and identify quality concerns.
Non-Conformance & CAPA
- Identify and report product and process non-conformities.
- Participate in Root Cause Analysis (RCA) investigations.
- Support implementation and monitoring of CAPA activities.
- Follow up on corrective actions to ensure effectiveness.
Documentation & Compliance
- Maintain quality records, logs, and inspection reports.
- Ensure adherence to ISO 13485 requirements and company quality procedures.
- Support document control and record retention activities.
- Ensure compliance with GMP and Medical Device regulatory requirements.
Shop Floor Supervision
- Monitor operator compliance with quality standards.
- Ensure proper handling of materials and products.
- Verify cleanliness and housekeeping standards in production areas.
- Coordinate with Production, Stores, and Maintenance departments for quality-related issues.
Audit Support
- Assist during Internal Audits, Customer Audits, and Regulatory Inspections.
- Ensure timely closure of audit observations related to the department.
Training & Awareness
- Conduct quality awareness training for operators and production staff.
- Guide employees on quality requirements and process controls.
Continuous Improvement
- Monitor rejection, rework, and defect trends.
- Suggest process improvements to reduce quality issues.
- Participate in quality improvement projects.
Qualification
- Diploma / B.Tech / B.E. in Mechanical, Biomedical, Production, Industrial Engineering or relevant field.
- B.Sc. / M.Sc. in Science disciplines may also be considered.
Experience
- 3–8 years of experience in Quality Assurance / Quality Control.
- Experience in Medical Device Manufacturing, Surgical Disposables, Catheters, PICC Kits, PD Kits, IV Devices, or Sterile Products preferred.
Required Skills
- In-Process Inspection
- Final Product Inspection
- ISO 13485 Awareness
- GMP Compliance
- CAPA Implementation
- Root Cause Analysis (RCA)
- Quality Documentation
- Shop Floor Quality Monitoring
- MS Excel & Reporting
- Team Coordination
Key Performance Indicators (KPIs)
- Reduction in Production Rejection
- Reduction in Rework Cases
- Compliance to Inspection Plans
- Timely Closure of Quality Issues
- CAPA Implementation Effectiveness
- Audit Observation Closure
- Process Compliance Score
- Documentation Accuracy
Preferred Candidate Profile
- Experience in Medical Device Manufacturing Industry.
- Strong understanding of Catheter, PICC Kit, PD Kit, Surgical Disposable, or Sterile Product manufacturing processes.
- Ability to work closely with Production and Quality teams to improve product quality and process efficiency.
- Good leadership, problem-solving, and communication skills.
Salary Range
Depending on Experience & Industry Exposure
Immediate Joiners Preferred
Pay: ₹30,000.00 - ₹40,000.00 per month
Work Location: In person
