Manager - Quality Engineering
Listed on 2026-09-21
-
Quality Assurance - QA/QC
-
Management
ABOUT US:
Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients.
Biodesix Diagnostic Tests
support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease.
Biodesix Development Services
enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics.
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
This is a hybrid role based in Louisville, CO
THE ROLE:
The 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 Management
JOB LOCATION: This is a hybrid role based in Louisville, CO
THE ROLE:
The 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 Management
WHAT YOU'LL DO:
Key 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 l3485 , 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,…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).