Manager - Quality Engineering

Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.

Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics. For more information, please visit www.biodesix.comJOB LOCATION: This is a hybrid role based in Louisville, COTHE ROLEThe Manager - Quality Engineering will have broad and critical responsibilities that include: overseeing quality policies, procedures, processes, programs, and practices associated with product realization activities (including pre and post launch), and documentation to demonstrate conformance with appropriate standards and regulations; supporting product development teams in the design practices and risk and hazard management processes associated with development of medical devices, assays, and diagnostic test services per the Biodesix Quality Management System (QMS); managing the Quality Engineering group and accountable for applicable quality systems, including but not limited to Product Development, Change Control, Risk Management, Supplier Management, and Materials ManagementWHAT YOU'LL DOKey Responsibilities Day-to-day management, development, and implementation of quality assurance programs by the Company. Deliver against Company goals to ensure core team projects are completed on time and meet the Company's quality standards. Manage the Quality Engineering Team and associated systems and personnel Strong collaboration with operations, managers, and product development staff. Monitor production and purchasing services or activities to improve accuracy, customer service, or safety. Development of validation plans for equipment, process, and devices. With Operations and Development leadership, examine existing procedures or opportunities for streamlining activities to meet product improvement needs. Contributor as the Quality function on verification & validation plans and reports. Leading the development of the risk management plan(s) for product realization. Assisting project teams on compliance with design requirements per CAP/CLIA, NYS CLEP and FDA Q M SR, European MD R/IVDR, ISO 13485, ISO 14971, and other applicable ISO/EN standards as applicable to the Company. Accountable for the following key functions within the Quality team Product Development Process: Design Control SOPs, Device Design History Files, Change Control, Risk Management, Quality/Process Improvement and Validation, Supplier and Material Management, Operational processes that impact quality All other duties as assigned Management Responsibilities Leads a team of employees Sets team strategy, priorities, and performance expectations aligned to organizational goals Drives talent development, succession planning, and workforce planning Provides ongoing feedback and conducts performance evaluations Promotes a culture of respect, collaboration, and belonging across the team and broader organizationWHAT YOU'LL BRINGKnowledge and experience with (CAP/CLIA, NYS CLEP), ISO 13485, LDT, Q M SR and Product Development. Good working knowledge of object-oriented concepts and application design principles. Clear understanding and experience implementing ISO 14971 :2019 Risk Management into a QMS.Previous experience in leading and participating in Product Development teams. Previous experience in managing and growing teammates. Working knowledge of developing equipment and/or process master validation plans. Must be a team player with strong customer orientation and ability to work within a diverse disciplinary cross-functional team environment. Strong verbal, written, organizational, time management and interpersonal skills. Experience with creation and execution of testing plans/reviewing functional specification documents. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Must be able to communicate effectively in a verbal and written format. The successful candidate will be: Able to perform all the required skills of this position with minimal direction. A detail oriented and quality minded individual with experience based good judgment. Strong computer skills, including working knowledge of MS Office and e-mail. WHAT YOU'LL GETAnnual Base Salary Range $100,000 – $116,000 Discretionary Bonus opportunity Comprehensive health coverage: Medical, Dental, and Vision

Insurance: Short/Long Term Disability and Life Insurance