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Quality Engineer (Medical Device)

DALLAS, TX, US
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COMPANY: ALYN, PATRICK & ASSOCIATES, INC.

JOB TYPE: Permanent, FullTime

Seeking a Quality Engineer to join a small company and to assist with formulating the Quality Strategy. This is a Senior role that is very visible. The candidate will perform risk analysis, verification engineering and validation. The role is located in Dallas. Responsibilities: This role is focused on all of the duties typical of a Quality Engineer during the design phase. Document Controls and executing the validation plan. Provide key guidance to Engineering teams through design controls. Implement continuous improvement for design processes. Qualifications: BS required, MS preferred 5 years with biomedical device firm as a Quality Engineer Extra consideration given to a dual skill set in Software Quality Validation Prior regulatory background Background in Opto-electronics Strong documentation experience Served as a liaison to the FDA Key or helpful words: Infrared, Zemax, ISO, 483, warning letters, DHF files, optical, decision support, Analytics, machine learning, QSR, QMS, CAPA, 510k, PMA, Visualization, Product Review, strategic, Regression, Software Test, ASQ, Code V, CMDR, QA, compliance, GCP, 820, cGMP All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, age or veteran status.
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