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Randstad Engineering
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Job Location: EXETER, NH
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A leading biomedical company is currently seeking a Quality Engineer to assist with the development of quality systems, procedures and controls to ensure that products consistently meet performance and quality specifications. Qualified candidates must have a BS in Electrical Engineering and at least 5+ years of Quality Engineering with a medical device manufacturing environment. This position will initially work out of the Baltimore/ Annapolis but will be moving to north of Boston. Candidates local to Boston who are willing to travel extensively to MD initially and then be considered for temp to perm once the operations are moved to the North Boston area would be ideal.
Responsibilities:
-> Works closely with R&D to ensure robust quality specifications for new products.
-> Quality review for electronic circuitry and components for new product development
-> Assists in writing, reviewing and executing design and process verifications and validations.
-> Performs light design for quality gauges and fixturing, reliabilityanalysis, problem solving and continuous improvement activities.
-> Assists in preparation and updates of manufacturing procedure documentation, and quality procedure documentation.
-> Analyze non-conformance event and complaint data analysis, investigate to determine root cause, proposes improvements, and maintain CAPA documentation.
-> Evaluates and monitors manufacturing issues, product concerns, and field complaints to determine opportunities for improving manufacturing and product performance.
-> Assists in internal quality audits and supplier audits.
Requirements:
-> Bachelor?s degree in Electrical Engineering or BS degree with electronic circuitry and component experience
-> 5 Years experience in quality engineering position at medical device company
-> Working knowledge of ISO 13485: 2003, 21 CFR, CMDR, other international regulations is highly desired
-> Proficiency in Solidworks or ProE
Benefits:
-> Health, Dental, Vision
-> 401 K
-> Paid Vacation and Holidays
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Randstad Engineering
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