
Quality Management System Coordinator
2 days ago
About the Role:
- We are seeking a highly skilled Quality Management System Coordinator to ensure our products meet quality, safety, and regulatory standards.
- The successful candidate will be responsible for implementing and maintaining a QMS that adheres to relevant medical device regulations.
- This role involves managing technical files, regulatory submissions, quality agreements, and internal procedures.
- You will provide QA/RA input and support for design and development activities to ensure compliance from the outset.
- Additionally, you will 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 & Skills:
- Deep knowledge of global medical device regulations and standards.
- Excellent problem-solving and attention to detail.
- Strong 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.
- Previous experience in QA/RA within the medical device industry is an advantage.
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