I am a senior consultant in medical device, providing consulting services for QMS (ISO13485/ CFR820), product files and regulatory submissions.
I have over 15 years’ experience in the medical device industry. This includes 12 years at an airway management company, working as Head QAC/RA Officer, Supply chain Manager, Project Manager and Sr. Project Developer and 5 years working in a tissue engineering company (under GLP/GMP) as Sr. R&D technician and QC supervisor.
Prior to working in the medical device industry, I started my professional career in a Chemical company as an Analytical R&D technician, and later as a Polymer Researcher in a Food & Biobased company.
I can fulfill various functions like e.g. QA/RA manager, Project manager/Expert member in D&D, Production and Supply chain projects, QC manager and Auditor.
My fields of expertise are in:
– Set-up/write/maintain design history files, technical dossiers, 510(k) dossiers and master files
– Project management design & development of medical devices
– Analytical chemistry / Polymer chemistry
– Equipment qualifications and validations (e.g. production, packaging, shelf-life)
– Manufacturing and sterilization methods (e.g. injection molding, 3D printing, extrusion, gamma/eto sterilization)
– Improvement processes in production and quality control
– Internal auditing and/or supplier auditing
– Communication with test laboratories (chemical, mechanical and biological tests) or with notified bodies/authorities
– Hands on support, coaching and training
– Biological safety evaluation of medical devices