4 months ago
Hamlyn Williams has partnered with a innovative medical technology based in Germany that is in a Major phase of growth and looking for a Quality Manager. This position offers 100% remote working
The role will involve:
- Reclassifying Software, this will include overseeing the software development process and supporting the risk management process
- Create documents for the technical documentation and prepare them for approval
- Support Regulatory Affairs in the approval process.
- Maintain and tailor the QMS in regards to the ISO 13485 and 21 CFR part 820 standards for medical device software
- Maintain the VAs, AAs and forms and prepare them for internal approvals.
- Support the QM training of the R&D team.
As a Quality Assurance manager you will need:
- Experience in the Medical Device/ Medical technology space,experience with software will be desired
- Able to work independantly and have ambition to progress in the company
- Fluent English speaking. German speaking skills will be desired but not essential
I am a Quality Assurance and Regulatory Affairs market specialist working with a large variety of clients across the Medical Device industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Leah at +44 020 3545 1118 or at email@example.com.