Quality Systems Engineer
A Quality System is responsible for the design, implantation and maintenance of Quality Systems in a medical device company.
Role/Responsibilities
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Quality System compliance to ISO9001, ISO13485 and Medical Devices Directive
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Represent EMEA on global quality initiatives
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Liaise with EMEA manufacturing sites and subcontractors
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Drive and implement Quality System Improvements Perform audits of subcontractors
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Perform internal audits
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Support external audits
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Manage CAPA and Event Investigations for site
Skills/Experience
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Engineer/Science qualification with minimum of 8 years working within QA/RA in a multi-national Medical Devices environment
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Attention to detail and accuracy - essential
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Ability to work well under deadlines and pressure
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Problem solving skills for developing creative solutions and meeting objectives are required
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Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
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Excellent analytical ability
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Communication skills
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The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.