The job As a QA and RA advisor your main responsibility will be to support our customers from the Medical Device Industry concerning the following:
Interface with other consultants and the client’s representatives to successfully manage projects, deliverables, and compliance with quality expectations and deadlines
Provide information and advice to clients on the regulatory and quality management processes for medical devices
Development of Quality Management Systems
Support to clients with Regulatory Affairs (MDR/IVDR)
Qmed Consulting is ISO 9001 and ISO 14155 certified, and you will be responsible, through your daily work, for the maintenance and ongoing implementation of the existing Quality Management System in all relevant areas.
Location: Office based or working remotely from home. Qualifications
3-5 years’ experience within the Medical Device Industry with knowledge of MDR, IVDR, FDA 21 CFR and ISO13485
Experience in planning and project management
Experience with electronic QMS is preferable
Conformity assessment routes according to European regulation
Excellent knowledge in English (spoken and written). Company language is English
Having structured work processes
Knowledge of LEAN methodology and Audits is not mandatory but an asset
As a person you are open and customer-minded with good interpersonal skills and a good sense of humour. You should be familiar with both teamwork and independent work in a changing work environment.
We offer an independent job with new challenges every day and a good and varied work environment.
For further information please contact Helene Quie by e-mail email@example.com or telephone +45 3050 3842.