Job Details
Medical Device Auditor
Job type: Permanent
Location: Home Based (USA) Travel 3-5 nights a week.
A leading global Medical Device Notified Body is currently seeking to hire a Medical Device Auditor to join their growing team in the North America. You will play a key role in the company s growth strategy and success of their business. Additionally, you will be able to make an immediate impact on their European operations with leading MedTech manufactures.
Key responsibilities of the Medical Device Auditor include:
- Perform 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
- Provide project management for North American-based Clients. This will include the issuing of quotes, coordinating multiple projects, coordinating audit team 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 with Active 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