Description
QA Project - Innovative Medical Device CompanyEPM Scientific are searching for a QA Consultant to work for a innovative Medical Device client I work closely with in the Netherlands. The project will entail preparing two sites for an FDA audit. The devices are varied (from class I to III) however, the majority of the devices are class IIb and III.
Please see a synopsis of the responsibilities of the role in question;
- Participate in external and internal audits
- Review and update technical files (risk management, DHF etc)
- Work with SOPs, CAPAs, change control and NCRs
The company is specifically search for candidates who are well versed with ISO13485: 2016, ISO14971: 2012, FDA and MDD/MDR
If you are interested in this position, please apply via the relevant links or contact me directly