Jeanette Andersson's Linkedin Analytics

After a year as Senior QA/RA Consultant at SDS MedTeq/Prevas with various global customers I have now moved on to become MedTech Teamlead at KeyPlants Malmö AB where we are building a team that can widen the KeyPlants offer to include Compliance, Quality Assurance and Regulatory Affairs for Medical Devices and Combination Products. Previously Quality and Regulatory Manager at TePe Group HQ. Responsible for QA and RA for HQ and 8 subsidiaries spread over the world for both Consumer Goods, Cosmetics and Medical Devices and combination products over markets with very diverse regulatory requirements. Also responsible for sustainability and environmental compliance via ISCC certification and ISO 14001 certification. Previously Manager the Manufacturing Quality Assurance team for medtech devices manufactured at Baxter Healthcare Lund. Also local process owner for regulatory required CAPA process. Very experienced at being audited and also at performing audits or heading projects. Genuinely interested in people and enjoy developing my team and people around me. Experienced change manager and stimulated by change and challenges. I am technically interested and thrive by learning new things. I am adaptable and focused on delivery on time and with high quality. Alongside of my career I have participated in quality audit trainings, performed global quality audits and accumulated experience within this field and I have passed an IRCA Approved Global Lead Auditor exam for ISO9000 standards. I have also performed many global and local ISO 14001, ISO 13485 and TL9000 internal audits. Specialties: Quality Management, Regulatory Affairs, Medical Devices, Combination Products, Authority Interactions, ISO standards, Internal Quality Audits, Management Reviews, Information Management, Project Management, SharePoint usability. QMS