Global Senior Auditor
Job type: Permanent
A leading international Medical Device company is currently seeking to hire an Auditor with background in medical devices to join their growing team in Germany. You will play a key role in the company's growth strategy and success of their business.
Your responsibilities will include, but are not limited to:
- Conduct audits (either desk-based or on client's sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective clients relationships.
- Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), MDSAP / Medical Device Single Audit Program (US, Canada, Brazil, Japan, Australia), and International quality system standards (e.g. ISO 13485)
- Creating and monitoring standard documents
- Work according to EU Regulations, 21CFR 820 and 2017/745
- Participate in risk management and complaint processing
Key requirements of the Auditor include:
- Minimum Degree Qualified - hold a BSc, Master's degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.
- An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
- Experience in MDSAP auditor
- Worked directly in Quality
- Experience with Risk Management EN ISO 14971
- Willingness to travel (domestic and international)
- Fluent in English
If you are interested in the role, apply online today, call +44 203 667 8385 or email your CV