Medical Device expertise related to Quality Assurance activities associated with the maintenance of medical devices, with a focus on MDR Class IIa inhalers. Activities include QA oversight and approval of the Design History File and Device Master Record, approval of design changes, QA approval the associated with change request cases, involvement on technical issues associated with the device portfolio, represent QA in the Post Marketing Surveillance activities, interactions and quality monitoring of third party companies involved in the manufacturing, maintenance of the Quality Agreements with third parties, contribute with the periodic management reports, support in the maintenance of the QMS, support in the maintenance of the ISO 13485 and EU MDR certification.
Medical Device Technical Expert - 50%
Global Pharma Company
Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!
Basic degree in scientific or relevant discipline (BS or equivalent)
As per Industry
At least 3 years of work industry experience or equivalent experience in a related industry is required along wirth excellent knowledge and understanding of the relevant requirements for design controls, as well as all QMS requirements for medical devices.
Englisch: Very good
If you are interested then kindly send your resume to: firstname.lastname@example.org