Principal Quality Engineer (Medtech)

TL;DR

Principal Quality Engineer (Medtech): Leading quality improvement initiatives across manufacturing operations with an accent on process capability, statistical analysis, and systemic defect prevention. Focus on architecting scalable quality systems, driving Lean/Six Sigma methodologies, and ensuring compliance with FDA QSR and ISO 13485 standards.

Location: On-site in Roseville, CA

Salary: $135,000 – $175,000

Company

hirify.global is a global healthcare company focused on innovative therapies for vascular and neuro conditions.

What you will do

• Lead cross-functional continuous improvement initiatives to reduce the Cost of Poor Quality and improve process capability.
• Identify and prioritize systemic quality improvements using advanced data analytics and structured problem-solving frameworks.
• Architect and optimize quality monitoring systems, including predictive analytics and statistical process control.
• Manage complex NCRs and CAPAs while ensuring alignment between product requirements and inspection strategies.
• Drive the adoption of advanced inspection technologies, automation, and risk-based acceptance strategies.
• Mentor and train Quality Engineers to foster a culture of scientific thinking and operational excellence.

Requirements

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical) required; advanced degree preferred.
• 7+ years of experience in Quality Engineering or Continuous Improvement within the medical device industry.
• Expert-level understanding of FDA QSR and ISO 13485 standards.
• Proven experience with Lean and Six Sigma methodologies.
• Advanced proficiency in statistical modeling, data analysis, and decision-making.
• Ability to work on-site in Roseville, CA.

Nice to have

• ASQ CQE or CSSBB certification.
• Experience with digital quality systems and advanced analytics platforms.
• Strong background in measurement system analysis and sampling theory.

Culture & Benefits

• Opportunity to influence long-term quality strategy and digital transformation.
• Collaborative environment working closely with R&D, Manufacturing, and Industrial Engineering.
• Exposure to laboratory and cleanroom environments.
• Professional development through mentorship and technical leadership roles.