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Job #03041

About our client Our client is an industry leader in the laser system arena. They focus on ultraviolet to mid-infrared technologies for their customers needs in medical applications. They address the needs of the medical marketplace by providing diverse, unique laser technologies tailored to demanding applications. For example, they can engineer lasers and light sources for many therapeutic areas, such as neurology, urology and dermatology. As well as being a rapidly growing company, they also offer a rewarding work environment. Their people enjoy challenging projects, interesting technical problems, opportunities for ownership, and a progressive learning culture. This is a challenging opportunity for the right candidate. Position Location Director of Quality Assurance/Regulatory Affairs Bothell, Washington Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and implement QSR as well as ISO 13485 compliant design change processes 2) Write or rewrite nonconformance and deviation documents to improve efficiency and use of systems 3) Work directly with document control to ensure flow of documents 4) Oversee the completion of engineering tasks related to development, documentation, validation and release of products 5) Develop and conduct training programs throughout the organization to ensure consistency in processes 6) Lead and participate in quality systems audits and document reports 7) Implement FDA GMP compliant manufacturing system 8) Review and approve all design documentation, manufacturing drawings, part drawings and manufacturing test procedures 9) Coordinate safety agency testing and approval 10) Provide input to proposals and project plans to ensure the product development process meets FDA approval Requirements 1) Degree in Engineering 2) Background in manufacturing and quality assurance 3) Experience in medical device manufacturing, quality assurance, regulatory compliance, submissions and test engineering in the medical device field 4) Knowledge of ISO 13485:2003 standards and/or FDA 21CFR820 compliance