
Quality Assurance Manager
4 days ago
Job Overview
Quality Management System (QMS)
We are seeking a Quality Assurance Specialist to implement and maintain a QMS like ISO 13485, ensuring our products meet quality, safety, and regulatory standards.
Regulatory Compliance
The ideal candidate will have deep knowledge of global medical device regulations and standards, identifying, interpreting, and ensuring adherence to relevant regulations for market entry and ongoing compliance.
Key Responsibilities
- 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, identifying and mitigating potential hazards.
- Support the management of supplier quality and compliance.
- Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
Required Skills & Qualifications
- Regulatory Expertise: Deep knowledge of global medical device regulations and standards.
- Problem-Solving & Attention to Detail: Crucial 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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