- Education: Bachelors in Science, Engineering or related field.
- Heavily Preferred skillsets- Medical device background/experience, understanding root cause, deviation management, CAPA, quality systems.
- The basic function of this position is to provide support to customer complaints, including ensuring the root cause appropriately considers the device and device constituents.
- Write and execute documentation, including Operational and Installation Qualifications and Validation
- Additionally, this position will be lead a cross functional team to update or create various risk documentation necessary to further support the customer complaint process and overall management of the device or combination product.
- Team supports more than 40 Medical Device and Combination Products (MDCP) including Asmanex Twisthaler, Dulera, Follistim, Ganirelix, Gardasil 9, Nasonex, Nexplanon (Implanon NXT), NuvaRing (and Applicator).
Engineer, root cause, deviation management, CAPA, quality , Installation Qualifications , Validation, Complaint, Deviation, Co-op, Process , Process Engineer, Combination Products, Medical Device , Pharma, Pharmaceuticals