Product Specialist - in-vitro diagnostics (IVD)
Job type: Permanent
Location: Bavaria
A leading Medical Device company headquartered in Bavaria with several offices within Germany and across Europe, Asia and America is looking to hire a number of experienced individuals with a background in in-vitro diagnostics and quality management systems.
This is a key hire in the companies strategic operational growth plans for 2021. Ideally, the client would like candidates to be based in Bavaria, but there is scope for home office for these roles.
Responsibilities:
- Meticulous assessment of quality management systems and technical documents in accordance to EU quality management standards and other regulatory frameworks,
- Assessment of technical documentation including, product reports and test results of production batches in the area of IVD of the highest risk category,
- Creating and monitoring standard documents
- Cooperation in implementing certifications and audits
- Participate in risk management and complaint processing
- Work according to EU Regulations
Requirements:
- PhD or M.sc with the natural sciences,
- 3 - 4 year's industry experience within the diagnostics industry, ideally development and quality assurance,
- Direct experience in quality management
- Broad knowledge of immunology, molecular biology and comparable techniques.
- Willingness to travel domestically and internationally
- Fluent German (C1), English.
