POSITION SUMMARY:The Quality Engineer (QE) will be responsible for management and execution of assigned quality projects in order to meet quality assurance objectives. The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment and the ability to work cross-functionally to support rapid growth and continuous improvement. This position primarily will support in-house manufacturing operations. PRIMARY DUTIES AND RESPONSIBILITIES:Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.)Evaluates product changes and directs appropriate disposition of product through the company’s change control systemAssemble non-sterile product into kits for final release into the fieldParticipate in setup, qualification, calibration, and maintenance of manufacturing and inspection equipmentResponsible for creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality productSupport concurrent engineering efforts by participating in design development projects representing quality assurance and the customer (supplier and end user)Responsible for creating and maintaining process risk management files to meet FDA and ISO standardsReviews product and documentation non-conformances and recommends inspection, product and/or quality system modificationsInterfaces with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implementedAssists in inspection of work-in-progress, finished parts and assemblies, kits and completion of associated paperwork for final release of productAssists in reviewing patient-specific instrumentation designsParticipates in projects and help drive and build a Continuous Improvement and Lean culture across the organization
