With a keen eye for improvement opportunities as well as being a talented organizer when things get tough, I like to take initiative and tend to find new paths. I have a knack for finding solutions where others got stuck. This has been of great value to the companies I thus far worked for. Besides being accomplished at my job, I always like to go the extra mile to be of added value to colleagues, customers and the company I work for. As a dedicated lifelong learner I like to rise to a challenge that requires the utmost of my intellect and my abilities.In the past I have worked on subjects in the following areas:• Supporting startups towards regulatory compliance by developing and using controlled quality processes• Regulatory strategies and compliance for medical devices, MDSW, non medical electrical and electronic equipment• Software test management• Complaint handling and CAPA management• Organizing people, workflows and tasks to meet external requirements and customer expectations.TechnicalQuality and quality management systemsITProject ManagementMedical device regulationRegulations on electrical equipment and installation products worldwide Certified/Trained/Experience in:• Process standards ISO 62304, ISO 13485, ISO 14971, ISO 14155, ISO 9001, ISO 62366• Electrical and Medical device product and compliance standards • Regulatory Supplier Management RAPS 2014• Auditing ISO 13485, ISO 9001• Adverse event and recall reporting, world wide• Internal/external auditing (on the job)• 8D, GMP, FMEA, SPC, Taguchi, LEAN ways of working.• Corrective and Preventive Action process (CAPA)• EU blue guide regulations, including MDR• FDA US Quality System Regulations (21CFR 803, 21CFR 806, 21CFR 807, 21CFR 820)• US federal product regulations (CDRH, FCC, OSHA and NFPA including NEC)• CCC, BIS, RCA, Denan and other world wide product regulations• Prince 2 Foundation• SQL• ISTQB• TMAP professional advanced• GC, HPLC, NMR, AAS, AES, SEM-EDX, ELISA• Statistical data analysisMy specialties: Share knowledge and work towards attainable solutions as a team in a pragmatic and logical way.