
Device Expert Leader
1 week ago
We are seeking a highly skilled and experienced professional to fill the role of Senior Device Engineer.
The ideal candidate will have a strong background in medical devices, quality management, and regulatory affairs. They will be responsible for assessing and auditing medical devices to ensure they meet the required standards.
- Minimum 10 years of experience in the medical devices industry, including research and development, manufacturing, and quality management.
- At least 5 years of experience in quality management is essential.
Key Requirements:
- Thorough knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
- Experience with Risk Management EN ISO 14971.
- Solid understanding of non-active devices and sterilization processes.
- Ability to work effectively in a team environment.
Requirements Summary:
• Experienced in medical device regulations
• Knowledge of ISO 13485, MDD, and IMDR
• Strong quality management skills
• Excellent communication and teamwork abilities
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