
Quality Management Professional
12 hours ago
Role Summary
Job Responsibilities:
- Implementing and maintaining a quality management system (QMS) to ensure products meet quality, safety, and regulatory standards.
- Ensuring adherence to relevant medical device regulations for market entry and ongoing compliance.
- Creating, reviewing, and controlling technical files, regulatory submissions, quality agreements, and internal procedures.
- Providing QA/RA input and support for design and development activities to ensure compliance from the outset.
- Participating in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
- Monitoring device performance in the market, investigating customer complaints and non-conformity, and managing vigilance reporting.
- Supporting the management of supplier quality and compliance.
- Conducting internal audits and leading initiatives to improve processes and ensure adherence to QMS requirements.
Requirements:
- 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.
Key Performance Indicators:
- Successful implementation and maintenance of QMS.
- Adherence to regulatory requirements and standards.
- Improved process efficiency and effectiveness.
- Enhanced quality and safety of products.
- Effective communication and collaboration with stakeholders.
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