Job Title: Quality Supervisor – Medical Devices Job Summary

The Quality Supervisor will be responsible for monitoring and ensuring product quality during the manufacturing of medical devices. The role involves supervising quality inspection activities, maintaining documentation, and ensuring compliance with regulatory standards such as ISO 13485 and FDA requirements.

Key Responsibilities

• Supervise incoming, in-process, and final quality inspections of medical device components and finished products.
• Ensure compliance with **International Organization for Standardization ISO 13485 quality management system requirements.
• Support regulatory compliance with **U.S. Food and Drug Administration FDA 21 CFR Part 820 guidelines.
• Review and approve inspection reports, quality records, and batch documentation.
• Identify and document Non-Conformance Reports (NCR) and ensure proper corrective actions.
• Lead Root Cause Analysis for quality issues and implement Corrective and Preventive Actions (CAPA).
• Coordinate with production, engineering, and regulatory teams to resolve quality issues.
• Participate in internal and external quality audits.
• Monitor quality KPIs and prepare quality performance reports.
• Train and guide junior quality inspectors and technicians.

Required Qualifications

• B.Tech / B.E in Mechanical Engineering or Biomedical Engineering
• 1–2 years of experience in Quality Assurance / Quality Control in the medical device or healthcare manufacturing industry.

Required Skills

• Knowledge of ISO 13485 quality standards
• Understanding of GMP (Good Manufacturing Practices)
• Experience with CAPA, NCR, and deviation management
• Knowledge of quality tools (7 QC tools, Root Cause Analysis, FMEA)
• Basic understanding of inspection tools and measurement techniques
• Strong documentation and analytical skills

Preferred Skills

• ISO 13485 Internal Auditor certification
• Experience with regulatory audits
• Knowledge of medical device regulatory requirements

Experience

• 1–2 years in Medical Device Manufacturing / Quality

Location

Hyderabad / Medical Device Manufacturing Facility

Job Type: Full-time

Pay: ₹25,000.00 - ₹35,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Work Location: In person