* Evaluate compliance of materials and/or processes with specification and customer requirements. * Collect, analyze and interpret statistical data. * Perform defect analysis on components, finished goods and complaints. * Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally. * Assist in Design of Experiments to improve process/product. * Interpret engineering drawings, schematic diagrams, or formulas and confer with engineering staff to determine quality and reliability standards. * Define a verification/validation process and develop protocols in conjunction with appropriate functions, perform analyses, and document results in a report format consistent with process requirements. * Mentor and coach other Quality Engineers. * Assist suppliers in developing inspection methods. * Perform Gage R&R/MSA's and correlation studies. * Perform Internal/External Quality System Audits. * Aid in the management of our subcontract suppliers. * Provide training and assistance to inspectors. * Work with QA Technicians to resolve measurement issues. * Work with QA departments to resolve blueprint/specification issues. * Develop Control Plans, Inspection Instructions and other documents as needed to effectively manage product/process quality both internally and at the suppliers. * Develop and review documented operating procedures associated with material inspection or processes. * Work directly with suppliers to prevent or correct discrepant material. * Other duties as assigned with or without accommodation. * Bachelor's of Science in Engineering, Quality Assurance or Life sciences or equivalent work experience. * 5 years of experience in the medical device industry in a Quality Engineering capacity or equivalent work experience. * Experience in a regulated environment (FDA, ISO, etc.). * Blueprint and specification reading, Geometric Dimensioning and Tolerancing. * Excellent verbal and written communication skills are required. * Demonstrated proficiency utilizing problem solving tools Six Sigma Tools (i.e., FMEA, DOE, SPC, C & E matrix etc.) and application of statistical techniques is desired. * Must be comfortable with MS Office Package, Minitab. * Familiarity with the sterilization methods and biocompatibility testing is a plus. * Six Sigma training, Certified Quality Engineer and/or Certified Quality Auditor a plus.
To find out more about Real please visit
www.realstaffing.com [1]
Links:
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[1]
http://www.realstaffing.com 