Quality Engineering Manager - Medical Devices (Hybrid)

Biodesix, Inc.; Louisville (CO); On-site; USD 100,000 - 116,000; Full time

Benefits offered by this job

Discretionary Bonus

Health Coverage (Medical, Dental, Vis

Vacation 120 hours

Sick time 72 hours

11 holidays + 3 floating

Employee Assistance Program

Voluntary Benefits

Recognition program

Job summary

Biodesix is seeking a Manager - Quality Engineering in Louisville, CO, a hybrid role that leads quality policies, processes, and documentation across product realization from development to post-launch.

You will guide the Quality Engineering team, ensure conformance with CAP/CLIA, NYS CLEP, ISO 13485, and FDA QMS standards, and collaborate with operations and development to improve product quality and regulatory compliance.

Qualifications

• Experience with CAP/CLIA, NYS CLEP, ISO 13485, and FDA QMS.
• Proven ability to lead and grow a Quality Engineering team.
• Strong understanding of risk management in medical device development.
• Experience with design controls and validation plans.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Oversee QA programs across product realization.
• Lead QMS, Change Control, Risk Management, Supplier and Material Management.
• Head development of risk management plans.
• Coordinate with operations and development for process improvements.
• Manage team performance and staffing.

Skills

Quality Engineering

CAP/CLIA Knowledge

ISO 13485

Risk Management

Leadership

Cross-functional collaboration

Regulatory Compliance

Documentation

MS Office

Job description

Biodesix is seeking a Manager - Quality Engineering in Louisville, CO, a hybrid role that leads quality policies, processes, and documentation across product realization from development to post-launch.

You will guide the Quality Engineering team, ensure conformance with CAP/CLIA, NYS CLEP, ISO 13485, and FDA QMS standards, and collaborate with operations and development to improve product quality and regulatory compliance.