Nancy Eben Fonskov holds a Master of Science in Mechanical Engineering from Aalborg University in year 1995.
Nancy possesses strong quality assurance and business knowledge within the Medical Devices and Pharma Industry. She has worked with Medical Devices and Pharmaceutical Packaging within the areas Quality Management, QC, R&D, Sourcing, Warehouse, Engineering and Production for 25 years.
Nancy can offer business consulting to comply with the Medical Device Directive 93/68/EEC, Medical Device Regulation 2017/745, ISO13485, ISO 15378 standard and US FDA QSR title 21 Code of Federal Regulations part 820.
Nancy possesses an examined ISO Lead Auditor background and, hereby, she has obtained solid experience with Business ISO Certificate Approvals, Internal-, Supplier- & Customer Audits and 3rd Party Inspections.
Furthermore, Nancy has skills in Quality Management Systems, LEAN, Q-process improvement and Operations e.g. Nonconformity/Deviation, Change Control, Complaints, EU & US GMP and GDP, and Supplier Management.
We are excited to welcome Nancy to Technolution as Quality Specialist.