Manager - Quality Engineering

Scorpion Therapeutics; Louisville (CO); On-site; USD 110,000 - 160,000; Full time

Job summary

Biodesix seeks a Manager - Quality Engineering to oversee quality policies, processes, and compliance for medical devices, assays, and diagnostic tests. You will lead the Quality Engineering team, manage quality systems (Product Development, Change Control, Risk Management, Supplier Management), and develop validation plans.

Collaborating with operations and development, you will streamline procedures, support design activities, and ensure compliance with ISO 13485, ISO 14971, CAP/CLIA, and FDA

Qualifications

• Bachelor's degree in a relevant discipline.
• 8+ years of quality assurance in biopharma/medical device sectors.
• Experience with validation, risk management, and quality systems.
• Demonstrated leadership experience managing teams.

Responsibilities

• Oversee quality policies, processes, and compliance for medical devices, assays, and diagnostics.
• Lead the Quality Engineering team.
• Manage quality systems including Product Development, Change Control, Risk Management, and Supplier Management.
• Develop validation and risk management plans.
• Ensure compliance with ISO 13485, ISO 14971, CAP/CLIA, and FDA QMSR.
• Collaborate with operations and product development to streamline procedures.

Skills

Leadership

QA

Quality Systems

Validation

Risk Management

Education

Bachelor's degree in a relevant discipline

Job description

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%).