
Highly Experienced Quality Assurance Specialist
2 days ago
Job Role:
Senior Device EngineerWe are seeking an experienced Senior Device Engineer to play a pivotal role in our Medical Devices-Assessor/Auditor team.
Main Responsibilities:
- Evaluate and assess medical devices to ensure compliance with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
- Develop and implement risk management strategies using EN ISO 14971.
- Collaborate with Assessors/Auditors to work on quality management projects.
- Conduct thorough reviews of non-active devices and sterilization processes to ensure adherence to regulatory standards.
Requirements:
- Minimum 10 years of professional experience in the medical devices industry or related activities.
- 5+ years of relevant professional experience in quality management.
- Solid knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
- Experience with Risk Management EN ISO 14971.
- Solid knowledge of non-active devices and sterilization processes.
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