qtec services GmbH
Carola Janeck is a highly experienced professional in the regulatory and quality affairs field, currently serving as Senior Manager Regulatory and Quality Affairs at qtec services GmbH. Previously, Carola held positions such as Regulatory Affairs Manager at the same company, Regulatory Affairs Specialist and Project Manager Regulatory Affairs & Compliance Services at Johnson & Johnson Medical GmbH, and Project Engineer at BCP AG -evolutionary concepts-. Carola began their career as an Industrial Mechanic at Nordischer Maschinenbau Rud. Baader GmbH & Co. KG. Carola holds Diplom-Ingenieurin degrees in Technisches Gesundheitswesen and Physikalische Technik from Technische Hochschule Lübeck.
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qtec services GmbH
The well-being of patients is our top priority. It satisfies us that, with our help, your products will be provided to the patients safely, effectively and on time. One of our goals is to be the most qualified and flexible partner alongside manufacturers of medical devices and IVDs. We are experts and are happy to accompany you individually in - Quality management (audits, QM systems) - Design control (clinical evaluations, requirements, risk, VV, PMS, ...) - Regulatory Affairs (international approvals)