Quality Assurance Manager

2 weeks ago

Bareilly, Uttar Pradesh, India beBeeQuality Full time ₹ 6,00,000 - ₹ 10,00,000

Job Title: Quality Management Professional

About the Role:

We are seeking an experienced Quality Management Professional to join our team. This is a challenging role that requires a strong background in quality management and regulatory affairs.

Key Responsibilities:
  • Develop, implement, and maintain a comprehensive Quality Management System (QMS) to ensure products meet quality, safety, and regulatory standards.
  • Conduct thorough reviews of relevant medical device regulations and provide guidance on compliance requirements.
  • Manage technical files, regulatory submissions, quality agreements, and internal procedures to ensure accuracy and adherence.
  • Collaborate with cross-functional teams to ensure QA/RA input and support for design and development activities.
  • Lead risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
  • Oversee supplier quality and compliance initiatives.
  • Conduct internal audits and lead process improvements to ensure adherence to QMS requirements.
Requirements:
  • Extensive knowledge of global medical device regulations and standards.
  • Critical problem-solving and attention to detail skills.
  • Excellent communication and coordination skills to work with internal departments and external stakeholders.
  • Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Prior experience in QA/RA within the medical device industry is highly desirable.

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