
Medical Device Quality Assurance Specialist
20 hours ago
The Medical Device Quality Assurance Specialist role involves assessing and auditing medical devices to ensure they meet industry standards. With a strong background in healthcare products or related activities, the ideal candidate will have at least 10 years of professional experience in quality management.
Key Responsibilities:
- Apply knowledge of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations to assess and audit medical devices.
- Experience with Risk Management EN ISO 14971 is essential.
- Work actively with a team of assessors/auditors to evaluate non-active devices and sterilization processes.
Requirements:
- Minimum 5 years of relevant professional experience in quality management.
- Solid knowledge of sterilization processes and non-active devices.
- Strong understanding of industry regulations and standards.
Benefits:
The right candidate will be able to effectively manage and mitigate risks associated with medical device development, ensuring compliance with regulatory requirements. In return, we offer a dynamic work environment, opportunities for growth and development, and competitive compensation.
What We Offer:
- A challenging and rewarding career opportunity in quality assurance.
- Professional development and training opportunities.
- A collaborative and supportive work environment.
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