
Senior Quality Assurance Specialist
1 day ago
We are seeking a highly experienced Device Engineer to lead our team in developing and implementing effective quality management systems.
The ideal candidate will have a strong background in medical devices, with expertise in regulatory requirements and quality management. They will be responsible for evaluating medical devices for compliance with regulations such as ISO 13485, MDD, and IMDR, as well as conducting risk management assessments using EN ISO 14971.
Key Responsibilities:
- Evaluate medical devices for compliance with regulations
- Conduct risk management assessments
- Develop and implement quality management systems
Requirements:
- Minimum 10 years of experience in medical devices or related field
- 5+ years of experience in quality management
- Strong knowledge of regulatory requirements
- Solid understanding of non-active devices and sterilization processes
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