
Medical Device Quality Assurance Specialist
2 days ago
This role focuses on ensuring the quality and compliance of medical devices.
Main Responsibilities:
- Implement and maintain a Quality Management System (QMS) to guarantee that products meet quality, safety, and regulatory standards.
- Identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
- Create, review, and control 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.
- Participate in 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.
- Support the management of supplier quality and compliance.
- Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.
Key Qualifications:
- Regulatory Expertise: Deep understanding of global medical device regulations and standards.
- Problem-Solving & Attention to Detail: Essential for interpreting regulations, documenting processes, and resolving issues.
- Communication Skills: To coordinate with internal departments and external stakeholders.
- Bachelor's Degree: 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 an advantage.
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