Manager - Quality Engineering

Role: Manager - Quality Engineering

responsible for overseeing quality policies, processes, and compliance for medical devices, assays, and diagnostic tests at Biodesix. Key responsibilities include leading the Quality Engineering team, managing quality systems (Product Development, Change Control, Risk Management, Supplier Management), developing validation and risk management plans, and ensuring compliance with standards such as ISO 13485, ISO 14971, CAP/CLIA, and FDA QMSR. The role involves collaboration with operations and product development, streamlining procedures, and supporting design and development activities.

Requirements: Bachelor's degree in a relevant discipline; 8+ years in quality assurance within biopharma/medical device sectors; experience with validation, risk management, and quality systems; leadership experience managing teams.

Preferred: familiarity with European MDR/IVDR, LDT, and advanced knowledge of QMS standards.

High-Value: focus on medical devices, diagnostics, and assays; quality management, validation, and risk processes; regulated environment (CAP/CLIA, FDA, ISO); Louisville, CO location with regular onsite work and minimal travel (~10%).