Quality Manager

Quality ManagerLocation: Noblesville, IN, 46060Quality Manager - Medical DeviceNexxt Spine LLC., one of the best-positioned companies in the medical device industry, seeks a Quality Manager to add to our dynamic team. Located in Noblesville, Nexxt Spine designs, manufactures, and distributes a rapidly expanding line of spinal productsSUMMARYFocus on management of quality systems and personnel, as well as utilizing best Quality practices for the effective and efficient development, transfer, and maintenance of products and processes throughout the product lifecycle.ESSENTIAL DUTIES AND RESPONSIBILITIESImplement FDA guidelines for cGMP & ISO 13485Maintain calibrations and gaging systemCollaborate with Engineering to establish product control plans and inspection documents.Internal auditing company-wide for adherence to SOPsSupplier evaluation, auditing, and monitoringManagement of Non-conforming Material Reporting systemManagement of Receiving Inspection of raw materials and purchased productsPerform IQOQPQs for equipment and processesOversee manufacturing Quality personnelQuality trending and reporting quarterly management reviewsImplement continuous improvement using statistically validated processesEnsure adherence to the Quality ManualVarious other tasks relevant to a growing businessQUALIFICATIONS Must be well-versed in ISO 13485.Must be self-motivated to produce high-quality parts.Must be able to effectively communicate at all levels.EDUCATION and/or EXPERIENCE Four-year college degree from an accredited university in a related field. Experience in an FDA-regulated manufacturing environment is preferred.Nexxt Spine LLC is an equal-opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits, and opportunities for professional growth.