Advanced Quality Assurance Professional

10 hours ago

Surat, Gujarat, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000
Job Description:

We are seeking a detail-oriented Quality Assurance Specialist to implement and maintain a Quality Management System aligned with ISO 13485 standards.

The successful candidate will ensure adherence to relevant medical device regulations for market entry and ongoing compliance, manage documentation, and collaborate with design and development teams.

Key Responsibilities include:

  • Implementing a QMS that meets quality, safety, and regulatory requirements;
  • Ensuring adherence to medical device regulations;
  • Managing technical files, regulatory submissions, and internal procedures;
  • Collaborating with cross-functional teams;
  • Participating in risk management activities;
  • Monitoring device performance and investigating customer complaints;
  • Supporting supplier quality and compliance management;
  • Conducting internal audits and improving processes.
Required Skills & Qualifications:

Regulatory Expertise: A deep understanding of global medical device regulations and standards is essential.

Problem-Solving & Attention to Detail: Strong analytical and problem-solving skills are crucial for interpreting regulations and resolving issues.

Communication Skills: Effective communication is key to coordinating with internal departments and external stakeholders.

Education: A Bachelor's Degree in a relevant field such as engineering or life sciences is required.

Experience: Previous experience in QA/RA within the medical device industry is highly desirable.

Benefits:

This role offers a unique opportunity to make a meaningful contribution to our organization and develop a strong understanding of regulatory requirements.

The ideal candidate will have a passion for quality assurance and excellent communication skills.

If you are a motivated professional looking to take on new challenges, we encourage you to apply.

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