Advanced Quality Control Professional

1 day ago

Cochin, Kerala, India beBeeRegulation Full time ₹ 8,00,000 - ₹ 11,00,000
Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to ensure the quality and safety of our products.

  • This role involves implementing and maintaining a Quality Management System (QMS) to meet quality, safety, and regulatory standards.
  • The candidate will identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Key responsibilities include creating, reviewing, and controlling technical files, regulatory submissions, quality agreements, and internal procedures.
  • The QA/RA input and support for design and development activities is crucial to ensure compliance from the outset.
  • The specialist will participate 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 are essential duties.
  • Supporting the management of supplier quality and compliance is also key.
  • Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements are critical skills.
Required Skills & Qualifications
  • Regulatory Expertise: In-depth knowledge of global medical device regulations and standards.
  • Problem-Solving & Attention to Detail: Essential for interpreting regulations, documenting processes, and resolving issues.
  • Communication Skills: Crucial for coordinating with internal departments and external stakeholders.
  • Bachelor's Degree: Required 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 highly desirable.

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