Quality Assurance Specialist
1 day ago
This role involves implementing and maintaining a Quality Management System (QMS) to ensure that products meet quality, safety, and regulatory standards.
Key Responsibilities:- Develop and implement strategies to maintain compliance with medical device regulations throughout the product life cycle.
- Ensure adherence to relevant standards and guidelines for market entry and ongoing operations.
- Manage documentation, including technical files, regulatory submissions, quality agreements, and internal procedures.
- Collaborate with cross-functional teams to provide QA/RA input and support for design and development activities.
- Analyze risks and develop mitigation strategies to prevent potential hazards.
- Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
- Oversee supplier quality and compliance management initiatives.
- Lead internal audits and drive process improvements to enhance QMS efficiency.
- Regulatory expertise: In-depth knowledge of global medical device regulations and standards.
- Problem-solving and analytical skills: Essential for interpreting regulations, documenting processes, and resolving complex issues.
- Effective 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 highly desirable.
This position requires a strong understanding of medical device regulations and standards, excellent problem-solving skills, and effective communication abilities. The ideal candidate will have previous experience in QA/RA within the medical device industry and a bachelor's degree in a relevant field.
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