Medical Device Quality Assurance Specialist

2 weeks ago

Morādābād, Uttar Pradesh, India beBeeQuality Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Medical Device Quality Assurance Specialist

The role of a Medical Device Quality Assurance Specialist plays a pivotal part in ensuring the quality and compliance of medical devices.

This position involves implementing and maintaining a Quality Management System (QMS) to meet regulatory standards, providing QA/RA input for design and development activities, and managing supplier quality and compliance.

Key Responsibilities:

  • Implementing and maintaining a QMS (e.g., ISO 13485) to ensure products meet quality, safety, and regulatory standards.
  • Identifying, interpreting, and ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Creating, reviewing, and controlling technical files, regulatory submissions (e.g., 510(k)), quality agreements, and internal procedures.
  • Providing QA/RA input and support for design and development activities to ensure compliance from the outset.
  • Participating in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitoring device performance in the market, investigating customer complaints and non-conformity, and managing vigilance reporting.
  • Supporting the management of supplier quality and compliance.
  • Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.

Requirements:

  • Regulatory Expertise: Deep knowledge of global medical device regulations and standards.
  • Problem-Solving & Attention to Detail: Crucial for interpreting regulations, documenting processes, and resolving issues.
  • Communication Skills: To coordinate with internal departments and external stakeholders.
  • Bachelor's 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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