Sr. Quality Technician

An innovative medical device company in North Indianapolis is looking to bring on a Sr. Quality Technician who will perform quality control inspection and quality management system tasks in support of development and manufacturing of Class III device. This position requires a strong understanding of inspection techniques, quality systems, and regulatory compliance.Duties and Responsibilities:InspectionPerform incoming dimensional inspection of mechanical parts, using common hand measuring instruments as well as optical inspection systemsMay develop optical inspection system programsPerform in-process visual inspection of insulin pump assembliesQuality System AdministrationCreates, reviews and stores quality management system records, especially inspection data and device history records (production travelers)Administers the calibration and maintenance system including on-site visits by calibration suppliersAdministers non-conforming material systemMay administer other quality management systems including document control and corrective and preventive action (CAPA)May participate in internal auditsAssists quality department hosting of external audits by Notified Body and FDAQualifications :High school diploma/GEDAt least 5 years experience in a medical device, automotive or aeronautics company manufacturing environmentAt least 2 years working as a QC inspectorExperience performing dimensional and visual inspection of mechanical parts to engineering drawings and specifications/standardsKnowledge of Geometric Dimensioning and Tolerancing a plusExperience with Keyence inspection systems a plusExperience inspecting welds a plusBasic knowledge of statistics a plus (including Minitab)Strong verbal and written communication skillsFamiliarity with MS Office applications