Product Quality Assurance Professional

1 week ago

Meerut, Uttar Pradesh, India beBeeQuality Full time ₹ 40,00,000 - ₹ 80,00,000

Job Overview

We are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality and safety of our products.

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Main Responsibilities

  • Implementing QMS: You will be responsible for implementing and maintaining a Quality Management System (QMS) that meets industry standards.
  • Regulatory Compliance: You will ensure that our products comply with relevant medical device regulations and standards.
  • Documentation Management: You will create, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
  • Design Control & Development Support: You will provide QA/RA input and support for design and development activities to ensure compliance from the outset.
  • Risk Management: You will participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Post-Market Surveillance & Vigilance: You will monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
  • Supplier Management: You will support the management of supplier quality and compliance.
  • Internal Audits & Process Improvement: You will conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.

Key Skills & Qualifications

  • Regulatory Expertise: You should have deep knowledge of global medical device regulations and standards.
  • Problem-Solving & Attention to Detail: You should be able to interpret regulations, document processes, and resolve issues effectively.
  • Communication Skills: You should be able to coordinate with internal departments and external stakeholders effectively.
  • Bachelor's Degree: You should have a degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Experience: Previous experience in QA/RA within the medical device industry is an advantage.

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