Quality Assurance Compliance Expert

1 week ago

Thāne, Maharashtra, India beBeeQuality Full time ₹ 18,00,000 - ₹ 25,00,000
Job Overview:

The Quality Assurance Specialist will be responsible for implementing and maintaining a Quality Management System to ensure products meet quality, safety, and regulatory standards.

Key Responsibilities:
  • Implement and maintain a Quality Management System (QMS) to guarantee products adhere to quality, safety, and regulatory requirements.
  • Interpret and ensure compliance with relevant medical device regulations for market entry and ongoing compliance.
  • Develop, review, and manage technical files, regulatory submissions, quality agreements, and internal procedures.
  • Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
  • Contribute to risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitor device performance in the market, investigate customer complaints, and manage vigilance reporting.
  • Support the management of supplier quality and compliance.
  • Conduct internal audits and lead initiatives to enhance processes and ensure adherence to QMS requirements.
Required Skills and Qualifications:
  • Deep knowledge of global medical device regulations and standards.
  • Critical problem-solving and attention to detail skills.
  • Effective communication skills to collaborate with internal departments and external stakeholders.
  • Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Previous experience in QA/RA within the medical device industry is an advantage.

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