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7 hours ago
We are seeking an accomplished senior medical device expert to lead our quality assurance initiatives. The ideal candidate will have a strong background in quality management, with a minimum of 10 years of professional experience in the field.
Key Responsibilities:- Conduct thorough assessments and audits of medical devices to ensure compliance with regulatory requirements
- Collaborate with a team of assessors/auditors to deliver high-quality projects
The successful candidate will have a solid understanding of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745. Experience with risk management (EN ISO 14971) and sterilization processes is also essential.
Required Expertise:
- Excellent knowledge of quality management principles and practices
- Experience with non-active devices and sterilization processes
We offer opportunities for career growth and development, a competitive compensation package, and a dynamic work environment.
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