Principal Quality Engineer (Medical Devices)

Location: On-site in Alameda, California, United States

Annual base salary: $150,000–$195,000

Company

hirify.global develops medical devices and operates manufacturing and quality engineering functions.

What you will do

• Lead cross-functional continuous improvement initiatives to reduce Cost of Poor Quality and improve process capability and Critical to Quality performance.
• Identify and prioritize systemic quality opportunities through data-driven analysis and structured problem-solving.
• Develop CTQ flowdowns connecting product requirements, process controls, and inspection strategies.
• Architect quality monitoring systems using predictive analytics, statistical process control, and automated data visualization.
• Lead complex investigations using DOE, regression modeling, multivariate analysis, and reliability modeling.
• Improve inspection systems, test methods, measurement capability, sampling, and risk-based acceptance strategies while mentoring Quality Engineers.

Requirements

• Bachelor’s degree in Engineering; Biomedical, Mechanical, Materials, Chemical, or a related discipline preferred.
• 7+ years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering within the medical device industry.
• Experience with Lean and Six Sigma, large-scale continuous improvement, Cost of Quality reduction, or CTQ deployment.
• Expert understanding of FDA QSR and ISO 13485 in a manufacturing context.
• Advanced data analysis, statistical modeling, decision-making, and cross-functional technical leadership skills.
• Ability to work on-site in Alameda, California, in office, laboratory, and cleanroom environments.

Nice to have

• ASQ CQE, CSSBB, or an equivalent advanced quality certification.
• Expertise in inspection technologies, destructive testing, sampling theory, and measurement system analysis.
• Experience implementing automation, digital quality systems, or advanced analytics platforms.

Culture & Benefits

• Cross-functional collaboration with Manufacturing Engineering, Industrial Engineering, Equipment Engineering, Operations Leadership, and R&D.
• Competitive compensation package with benefits and equity when applicable.
• Business travel of 0%–10%.
• Work includes office, laboratory, and cleanroom environments, with potential exposure to bloodborne pathogens.
• Physical requirements include lifting up to 25 pounds and moving between buildings and floors.