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 continuous improvement methodologies. Focus on architecting scalable quality systems, mitigating systemic risks, and driving operational excellence in a medical device manufacturing environment.

Location: Must be based in Alameda, CA (On-site)

Salary: $150,000–$195,000

Company

hirify.global is a global healthcare company focused on innovative therapies for patients with 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.
• Architect and optimize quality monitoring systems, including predictive analytics and statistical process control.
• Develop and deploy CTQ flowdowns to align product requirements with process controls and inspection strategies.
• Drive high-complexity problem-solving efforts using advanced statistical methods like DOE and regression modeling.
• Influence long-term quality strategy, including digital quality transformation and advanced analytics integration.
• Train and mentor Quality Engineers to foster a culture of scientific thinking and operational excellence.

Requirements

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related); advanced degree strongly preferred.
• 7+ years of experience in Quality Engineering or Manufacturing Engineering within the medical device industry.
• Expert-level understanding of FDA QSR and ISO 13485 standards.
• Proven experience with Lean and Six Sigma methodologies and large-scale continuous improvement programs.
• Advanced skills in data analysis, statistical modeling, and cross-functional leadership.
• Must be able to work on-site in Alameda, CA.

Nice to have

• ASQ CQE, CSSBB, or equivalent advanced quality certification.
• Deep expertise in inspection technologies, destructive testing, and measurement system analysis.
• Experience implementing automation or digital quality systems.

Culture & Benefits

• Opportunity to influence long-term quality strategy in a dynamic, fast-paced environment.
• Collaborative work environment across Manufacturing, Industrial, and R&D engineering teams.
• Exposure to advanced manufacturing, laboratory, and cleanroom environments.