Quality Assurance Engineer – Medical Devices

Department: Quality & Compliance
Company: Meditronix Healthcare Pvt. Ltd.
Location: Pune, Maharashtra
Employment Type: Full-Time
Experience Level: 2–4 years
Salary Range: ₹5,50,000 – ₹7,50,000 per annum
Posted On: October 1, 2025
Application Deadline: November 15, 2025

Job Description

We are seeking a detail-oriented Quality Assurance Engineer to join our medical device manufacturing team.
You will be responsible for implementing and monitoring quality control processes, ensuring regulatory compliance, and improving product reliability for life-saving medical appliances.

Key Responsibilities

• Develop and execute quality assurance protocols and test plans for medical appliances.
• Collaborate with R&D to review product specifications and validate performance.
• Ensure compliance with ISO 13485 and FDA 21 CFR Part 820 standards.
• Maintain documentation of testing, inspection, and corrective actions.
• Participate in internal audits and supplier quality evaluations.

Required Qualifications

• Bachelor’s degree in Biomedical, Mechanical, or Electrical Engineering.
• Minimum 2 years of experience in medical device quality assurance or manufacturing.
• Knowledge of ISO and FDA regulatory frameworks.
• Hands-on experience with calibration and testing tools.
• Strong analytical and documentation skills.

Benefits

• Health insurance coverage
• Performance-based bonus
• Annual health check-up
• Training and certification support
• Cafeteria and transport facilities

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