QA Manager

3 days ago

Kota, Rajasthan, India beBeeQuality Full time ₹ 8,00,000 - ₹ 12,00,000

We are seeking a skilled professional to implement and maintain a quality management system (QMS) that ensures products meet quality, safety, and regulatory standards. The ideal candidate will possess in-depth knowledge of global medical device regulations and standards.

  • Implementing and maintaining a QMS 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, 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.
Key Skills & Qualifications

Regulatory Expertise: Deep understanding of global medical device regulations and standards is crucial for this role.

Problem-Solving & Attention to Detail: Excellent problem-solving skills, with a keen eye for detail, are required to interpret regulations, document processes, and resolve issues.

Communication Skills: Strong communication skills are necessary to coordinate with internal departments and external stakeholders.

Education & Experience: A Bachelor's Degree in a relevant field such as engineering, life sciences, or a related technical discipline is essential. Previous experience in QA/RA within the medical device industry is an advantage.

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