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Randstad Engineering
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Job Location: PROVIDENCE, RI
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Immediate 6 month contract position in RI for a Sr Software Quality Engineer with 5-8 years medical device experience. The right candidate will be responsible for ensuring all deliverables meet all company requirements & corporate procedures for equipment and automated systems, also the governing regulations for equipment and software validation. Must have 5-8 years quality / regulatory experience, in equipment and software validation and a BS in Engineering. Apply Now.
Responsibilities:
-> Perform as Senior Software Quality Engineer for the installation of new sterilization equipment and software
-> Create and/or approve, or assist in the creation of and approval of Equipment and Automated Systems (E&AS) and site deliverables, including, equipment / software User Requirements Specifications, functional specifications & documentation trace matrix
-> Installation verification and operational testing (IV/OT) deliverables for equipment and software
-> Hazard analysis for equipment and software related deliverables
-> Server back-up documentation, disaster recovery documentation, User Controls
-> IQ, OQ, PQ validation testing deliverables
-> Implementation deliverables (Change assessment documentation, procedural updates, etc.).
-> Experience with .net is a plus
Requirements:
-> BS degree in engineering or equivalent related experience
-> 5 - 8 years quality / regulatory experience
-> 5 - 8 years? experience in equipment and software validation
-> Expert knowledge in governing regulations for equipment and software validation
-> ASQ Certification a plus
Related Words: medical device, medical, compliance, quality requirements, boston scientific, products, medical equipment, documentation, fda regulations, iq, oq, pq, installation verification, perational testing, iv/ot, change assessment documentation
Randstad Engineering
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