Medical Device Auditor
3 days ago
Active Medical Device Auditor
Job type: Permanent
Location: Remote (USA) - Extensive travel required
Skill Alliance is seeking a Medical Device Auditor to join their growing team in the North America. As a key member of the company's growth strategy, you will play a pivotal role in the success of their business. Additionally, you will be able to make an immediate impact on their European operations with leading MedTech manufacturers.
Key responsibilities of the Medical Device Auditor include:
- Performing regulatory audits of clients, as well as evaluations of regulatory submissions which include Technical File Review, according to EU directives (MDR) and the MDSAP
- Reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body
- Providing project management for North American-based clients. This will include the issuing of quotes, coordinating multiple projects, coordinating audit teams and interacting directly with the customer
Key requirements of the Medical Device Auditor include:
- The ideal candidate should have a strong background in the production, validation, engineering or development side of the Medical Device industry
- Direct involvement in the Quality Management System (QMS) of a Medical Manufacturer. Experience in Active Medical Device products is relevant
- At least 4 years hands-on medical device experience in order to qualify for Notified Body Auditor status
- Regular travel across the North American region (USA, Canada and potentially Brazil/Puerto Rico) is required
- University degree in Engineering or Sciences; Biomedical, Electrical, Industrial, Biology, Chemistry or Physics
Please reach out to Skill Alliance for more information
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