
Medical Device Quality Assurance Specialist
4 days ago
Job Title: Medical Device Quality Assurance Specialist
Role OverviewWe are seeking a highly experienced quality assurance professional to ensure compliance with regulatory requirements in the medical devices industry.
Key Responsibilities:- Assess and audit medical devices to guarantee adherence to established standards.
- Collaborate with a team of experts to achieve common goals and promote quality management.
- At least 10 years of experience in quality assurance, research and development, manufacturing, or regulatory affairs within the medical devices sector.
- 5+ years of experience in quality management is essential for this position.
- Familiarity with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, MDR 2017/745, MDSAP, and IMDR.
- Proficiency in Risk Management EN ISO 14971 is highly valued.
- Solid knowledge of non-active devices and sterilization processes is necessary.
The ideal candidate will be responsible for ensuring the highest level of quality and compliance in our medical devices. A motivated and experienced professional with a strong background in quality assurance will thrive in this role.
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