Medical Device Auditor
Medical Device Auditor
Salary : $110,000 - $140,000
Location: USA (travel up to 80%)
A leading global Medical Device Notified Body is now looking for Active Medical Device Auditors to join their growing team in the US. You will play a key role in the company's growth strategy and business success. In addition, you will be able to make an immediate impact on their America operations with leading MedTech manufactures.
Responsibilities:
- As an auditor / product expert medical for active medical devices, you are responsible for auditing medical device manufacturers on the basis of EC Directive 93/42/EEC and Regulation (EU) 2017/745 and the standards EN ISO 13485 and EN ISO 9001.
- You will review the product documentation (technical documentation) in the field of active medical devices on the basis of the relevant regulations, e.g. EN 60601, EN 62304 et seq. and relevant EC directives / regulations, including standard-compliant documentation.
- In addition, you will write reports and documentation for certification.
- You are the point of contact for our customers in the medical technology sector.
- Comprehensive training and appropriate further training are a matter of course for us. We support you in becoming an auditor / lead auditor and promote your professional training and further development in your product expertise.
Requirements:
- Degree in natural sciences or engineering from a university/university of applied sciences (e.g. medical technology, electrical engineering)
- At least 4 years of professional experience. Of which at least 2 years in the field of development, production, quality assurance, quality management or regulatory affairs of active medical devices or software
- Experience in dealing with the EC Directives/EC Regulation for medical devices as well as the applicable standards for QM systems and medical devices
- Basic knowledge in the field of approval of medical devices
If you're interested in this role, please apply now!
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