Medical Devices Quality Assurance Specialist

9 hours ago

Bengaluru, Karnataka, India beBeeQuality Full time ₹ 12,00,000 - ₹ 15,00,000

Our company is seeking a highly skilled and experienced Quality Assurance Specialist to join their ranks. This individual will be responsible for managing quality assurance procedures and records, planning and guiding lab tests for innovative medical devices, and preparing and submitting device dossiers to regulatory bodies.

Main Responsibilities:
  • Manage quality assurance procedures and records.
  • Plan and guide various lab tests for innovative medical devices.
  • Prepare and submit device dossiers to regulatory bodies as per client needs.
  • Plan and conduct internal audits.
  • Participate in the corrective and preventive action process.

This role also involves imparting QMS training to new team members, identifying regulatory design input for design teams, and ensuring medical standard compliance. The ideal candidate will work closely with cross-functional teams to ensure good quality project deliverables.

To be successful in this role, you should have hands-on experience implementing quality management systems (QMS) such as ISO 13485. You should also have knowledge of Indian Medical Device Rule, 2017, and IEC standards like ISO 14971 and IEC 60601-1. Additionally, you should have excellent analytical and reviewing skills, strong communication and presentation skills, and a focus on achieving goals and delivering results.

Requirements:
  • Hands-on experience implementing quality management systems (QMS)
  • Knowledge of Indian Medical Device Rule, 2017, and IEC standards like ISO 14971 and IEC 60601-1
  • Excellent analytical and reviewing skills
  • Strong communication and presentation skills
  • Focused on achieving goals and delivering results
Benefits:

You will be working in a dynamic environment with opportunities to learn and grow. Our team is committed to excellence and we are looking for individuals who share our passion for quality and innovation.

About Us:

We value our employees and offer competitive benefits packages. If you are a motivated and talented individual who is passionate about quality and innovation, we encourage you to apply.

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