Device Quality Assurance Specialist
1 day ago
A senior-level professional with a strong background in medical devices and quality management is sought to join our organization. This exciting opportunity involves assessing and auditing medical devices to ensure compliance with regulatory requirements.
- The ideal candidate will possess a minimum of 10 years of experience in the medical devices industry or a related field.
Responsibilities include collaborating with cross-functional teams to develop and implement quality management systems, providing expert guidance on risk management, non-active devices, and sterilization processes, and working closely with a team of assessors/auditors to achieve shared goals.
Requirements:- Minimum 10 years of experience in the medical devices industry or related field.
- 5+ years of experience in quality management, including knowledge of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
- Experience with Risk Management EN ISO 14971 and solid knowledge of non-active devices and sterilization processes.
Interested candidates can submit their applications or share their updated CVs.
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