Kem Jakobsen holds a Technical Engineering degree in Operation and Management from the Technical Institute of Copenhagen in year 1991.
With more than 25 years expertise within the field of QA/RA/QC Operations based in the business of Medical Device & Pharma Industries, Kem can offer business consulting to comply with Medical Device Directive 93/68/EEC, Medical Device Regulation 2017/745, Combined Medicine & Medical Device product Directive 2001/83/EC, ICH guidelines, ISO13485 standard and US FDA QSR title 21 Code of Federal Regulations part 820 and part 4 due to assembly, manufacturing, clinical and commercial aspects.
Kem possesses an examined ISO Lead Auditor background and, hereby, he has obtained solid experience with Business ISO Certificate Approvals, Internal-, Supplier- & Customer Audits and 3rd Party Inspections.
Furthermore, Kem has skills in Quality Management Systems, Q-process improvement and Training, Quality Business Strategy and Operations e.g. Nonconformity/Deviation, Change Control, Complaints, EU & US GMP and GDP, and Supplier Management.
We look forward to benefiting from Kem’s many skills as a Quality Assurance Specialist. We are happy to welcome Kem as part of team Technolution.