Quality Engineer III

Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Quality

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A family-owned company, bioMerieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description Position Summary This is a full-time exempt position. The Quality Engineer III is responsible for assisting with the maintenance of technical aspects of the Quality Management System, specifically the control of Design and Development Changes. This person will be working with BioFire employees outside of Quality Assurance on a day-to-day basis and must have a customer focused attitude.  The person represents Quality Assurance on complex technical and process issues.  They are an advisor to assist resolving problems where they support specialty experts and guide process compliance. Primary Duties * Performs all work in compliance with the company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System * Perform duties of a Quality Engineer II without direct supervision * Lead the NCR, CAPA, validation and risk management systems to ensure the following: * Relevant procedures and requirements are considered and applied * Timely completion of activities * Lead and guide teams with investigation methodologies and validation strategies * Document notes, action item recording and follow through, and communication to senior leaders as needed * Manage large and/or complex projects when assigned * May study, develop and report Quality related metrics * Mentorship of lower-level Quality Engineering staff * Drive efficiency and consistency through continuous improvement in the Change Control process. * Develop and implement policy and procedures for site Change Control within corporate and regulatory standards. Conduct gap assessments as needed for changing corporate and regulatory guidance. * Maintain site change control process, ensuring compliance to global procedure and continuously improve the process to support site. * Participate in TrackWise Digital Change Control process and enhancements * Maintain process for using TWD tool for change control. * Coordinate and lead cross-functional meeting with multiple departments to review change assessments and plans (Change Control Board). * Collect change review request for the Change Control Board. * Prioritize and generate agenda and communication for Change Control Board. * Ensure change notice and presentation conform to the procedure, review with change owners, prior to Change Control Board. * Assess and approve change notifications to evaluate if proposal satisfies company standards. Ensure change proposals have comprehensive rationale, impact assessment, implementation plans and follow up actions documented. Ensure all approved actions are implemented as per commitment. * Provide advice and mentorship to cross-functional teams to enable successful and compliant change controls. Support teams in conducting impact assessments for the change. * Work closely with risk management documentation to ensure proper change assessments. * Approve the Change Record in the Trackwise Digital Tool * Close the Change Record in the Trackwise Digital tool with the Change Summary has been completed and approved. * Present business critical and regulatory impactful change controls and metrics to senior leadership. * Use TrackWise digital reports and dashboards to monitor change records * Develop, implement, and mon itor metrics for... For full info follow application link.