Alexander Knowles
Senior Compliance Engineer at OrganOx- Claim this Profile
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Bio
Experience
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OrganOx
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United Kingdom
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Medical Equipment Manufacturing
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1 - 100 Employee
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Senior Compliance Engineer
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Nov 2021 - Present
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Medical Device Quality Engineer
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Jan 2020 - Nov 2021
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Intersurgical
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United Kingdom
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Medical Equipment Manufacturing
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400 - 500 Employee
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Technical File Analyst
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Jan 2017 - Jan 2020
In my role as a Technical File Analyst I lead technical project within the research and development department to produce test data and technical file summaries for respiratory care product. Technical summaries were primarily used for the to gain CE certification and meet ISO and Medical Device Directive (MDD) requirement, but are are also used in new product development and to produce customer technical bulletins. I managed a team of testing analysts, who aid in production and assessment of data, and with whom I aid in career development. In the development of new respiratory care products I worked closely with departments including Marketing, Design and Production from product concept, aiding in design brief considerations, to launch to ensure that Intersurgical adhered to all technical aspects, and that the product was safe, legal and effective, through clinical use testing. With the technical laboratory team, product monitoring was continuously enforced to ensure conformance to the CE marking requirements and MDD is maintained. Test method and internal protocols are continually improved to achieve greater efficiency and accuracy, which allows opportunities for creative problem solving. Show less
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Technology Product Assurance Team Leader
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Sep 2015 - Jan 2017
I lead in safe laboratory testing and the development of products to a high standard. I collaborated closely with Engineers and Designers, working as a team to ensure industrial coffee machines function efficiently and meet customer expectations. I line managed 3 analysts, advising on laboratory techniques and reports. I maintain COSHH records, conduct risk assessments and validate products; writing operating procedures and ensuring compliance. Additional duties include acting as statistician for R&D and help with the implementation of laboratory standard ISO 17025, and further to my role joined the internal auditing team. Show less
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Intersurgical
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United Kingdom
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Medical Equipment Manufacturing
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400 - 500 Employee
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Research Technician
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Jan 2013 - Sep 2015
Part of the research and development team in a respiratory medical supplies company. To support the marketing of existing products, product development and improvements through laboratory testing as well as technical and commercial research. Part of the research and development team in a respiratory medical supplies company. To support the marketing of existing products, product development and improvements through laboratory testing as well as technical and commercial research.
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Education
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University of Sussex
Bachelor of Engineering (BEng), Mechanical Engineering