
Quality Control Manager
8 hours ago
Quality Assurance Specialist
Job Responsibilities- Maintain Quality Management Systems (QMS) to ensure products meet quality and safety standards.
- Interpret medical device regulations for market entry and compliance.
- Create, review and control technical files, regulatory submissions and internal procedures.
- Provide QA/RA input for design and development activities.
- Participate in risk management activities throughout the product life cycle.
- Monitor device performance and manage vigilance reporting.
- Manage supplier quality and conduct internal audits.
- Regulatory Expertise: Deep knowledge of global medical device regulations.
- Problem-Solving & Attention to Detail: Crucial for interpreting regulations and resolving issues.
- Communication Skills: To coordinate with internal departments and external stakeholders.
- Bachelor's Degree: In a relevant field such as engineering or life sciences.
- Experience: Previous experience in QA/RA within the medical device industry is an advantage.
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