
Quality Assurance Expert
2 weeks ago
We are seeking a highly skilled Quality Assurance Specialist to implement and maintain a robust Quality Management System (QMS) that ensures our products meet stringent quality, safety, and regulatory standards.
The ideal candidate will have a deep understanding of global medical device regulations and standards, as well as strong problem-solving and attention to detail skills. They will be responsible for implementing and maintaining a QMS that meets regulatory requirements, ensuring adherence to relevant medical device regulations, and managing technical files, regulatory submissions, and internal procedures.
The Quality Assurance Specialist will also provide QA/RA input and support for design and development activities, participate in risk management activities throughout the product life cycle, and monitor device performance, investigate customer complaints, and manage vigilance reporting.
In addition, they will support supplier quality and compliance management, conduct internal audits, and lead process improvement initiatives.
Required Skills and Qualifications- Deep knowledge of global medical device regulations and standards.
- Strong problem-solving and attention to detail skills.
- Effective communication skills for coordination 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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