Principal Quality Engineer (Medical Devices)

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

Salary: $150,000–$195,000 annual base salary

Company

hirify.global operates in the medical device manufacturing industry.

What you will do

• Lead cross-functional continuous improvement initiatives across manufacturing operations to reduce Cost of Poor Quality, improve process capability, and strengthen Critical to Quality performance.
• Identify, quantify, and prioritize systemic quality opportunities using data-driven methods, advanced analytics, and structured problem-solving.
• Develop CTQ flowdowns that align product requirements, process controls, and inspection strategies.
• Architect and optimize quality monitoring systems using predictive analytics, statistical process control, and automated data visualization.
• Lead complex problem-solving with DOE, regression modeling, multivariate analysis, reliability modeling, and other advanced statistical and scientific methods.
• Improve inspection systems, test methods, measurement capability, sampling, automation, risk-based acceptance strategies, and digital quality transformation while training and mentoring Quality Engineers.

Requirements

• Bachelor’s degree in Engineering, preferably in Biomedical, Mechanical, Materials, Chemical, or a related discipline; an advanced degree is strongly preferred.
• 7+ years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering within the medical device industry.
• Experience with Lean and Six Sigma methodologies, large-scale continuous improvement, Cost of Quality reduction, or CTQ deployment programs.
• Expert-level understanding of FDA QSR and ISO 13485 in a manufacturing context.
• Proven ability to lead cross-functional teams through complex technical challenges and strategic quality initiatives.
• Advanced data analysis, statistical modeling, and decision-making skills.

Nice to have

• ASQ CQE, CSSBB, or an equivalent advanced quality certification.
• Deep expertise in inspection technologies, destructive testing, sampling theory, and measurement system analysis.
• Experience implementing automation, digital quality systems, or advanced analytics platforms.
• Strong collaboration with Manufacturing Engineering, Industrial Engineering, Equipment Engineering, and R&D.
• Ability to thrive in a dynamic, fast-paced environment while influencing long-term quality strategy.

Culture & Benefits

• Competitive compensation package with benefits and an equity program when applicable.
• Work in general office, laboratory, and cleanroom environments.
• Business travel of 0%–10%.
• Potential exposure to bloodborne pathogens and requirements to lift or move up to 25 pounds.
• Ability to move between buildings and floors, remain stationary, use standard office equipment, and communicate accurate information across the organization.