Medical Device Quality Assurance Specialist JB-4146

We are looking for an experienced medical device quality assurance specialist to join a leading company in accelerating regulatory approvals, providing certification solutions, quality assurance and clinical studies in medical devices and digital medicine.

The company serves local and international companies and serial entrepreneurs who are at the forefront of professional and academic work in the field.

The role includes:

Working in a multidisciplinary project team that provides the best solution for all aspects of medical devices, including digital medicine, regulation, international sales approvals, clinical studies and usability engineering.

Responsibility for planning and implementing professional tasks in the areas of quality assurance in order to achieve the client's quality goals.

Interface closely with the client under the professional guidance of the company's project managers.

8-10 years of experience in medical device quality assurance - mandatory

High expressive ability in writing and Fluent in English - Required

Experience in establishing and managing a quality system for FDA and MDR requirements - Required

Experience in QMS audits and third-party audits - Required

Background in software and validations - Advantage

CQE certificate/Engineering degree - Advantage

Presentation and service

Willingness to work from client offices"