Lee Ambolt
Software Documentation Consultant at Caredx, Inc
Based in Lund, Sweden
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Seniority
Staff
Department
Other
Location
Lund
Industry
Biotechnology Research
Company size
792
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l•••••••@caredx.com
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Background
About Lee Ambolt
After 4 years of interesting, demanding, educational, inspiring and entertaining years at Immunovia, it's time to find a new place to fit in. I am currently a consultant with SolidX, looking for placements primarily within the medtech/life sciences industry but am open to new challenges in other areas. I'm a quick learning "Jack of All Trades" that can fit into the requirements of different roles and have a long experience in working in the interfaces between different departments, people, skillsets, equipment, techniques and knowledge My background includes physics doctorate research in Quantum Dot Lasers, a brief stop in the computer games industry working with export tools, and a long career as a Medical Physicist, state registered in the UK and in Sweden, specialising in radiotherapy, particularly in the installation, commissioning, QA and maintenance of clinical linear accelerators (Elekta, Varian, Tomotherapy among others), with field service engineer qualifications and physicist qualification. From there into life science at Prevas and now SolidX, I worked with QuickCool and now Immunovia, with a wide range of roles and responsibilities including setting up test rigs, acquiring test data and reviewing Clinical Evaluation Data, maintaining equipment, including QC and calibration, and documentation within a 13485 QMS. Later I worked with the In-vitro diagnostic IMMray test, writing QMS documentation within the MDR/IVDR/13485/14971 frameworks, including product specification writing, and development, testing, specifications and management of in house production, development and analysis software within the 62304 standard, using cloud based services connected to web based front end (of which I designed and developed in conjunction with R&D department and users of the software). I worked with data analysis, exporting data to Jupyter Notebooks and writing scripts (python) for performance trending reports, analysis and input to CAPA board reviews and evaluations. English native speaker, fluent in Swedish.
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