Quality Engineering Manager (Medical Devices)

TL;DR

Quality Engineering Manager (Medical Devices): Lead a team of Quality Engineers supporting manufacturing operations and production lines for medical devices with an accent on manufacturing quality performance, inspection strategy, yield improvement, and sustaining process control. Focus on partnering with Manufacturing Engineering and Production to build quality into processes, drive continuous improvement using Lean and Six Sigma, and ensure compliant performance through risk management and data-driven monitoring.

Location: Alameda, CA (onsite, office/laboratory/cleanroom environments)

Salary: $145,000 to $214,000

Company

Global healthcare company designing, developing, manufacturing, and marketing innovative therapies for challenging medical conditions.

What you will do

• Lead Quality Engineering support for product portfolios and production lines.
• Serve as primary quality partner to Production, Manufacturing Engineering, and Industrial Engineering.
• Own manufacturing quality metrics including yield, scrap, productivity, and throughput losses.
• Advance inspection strategies, test methods, process monitoring, and digital quality tools.
• Drive yield improvements and process capability using Lean and Six Sigma methodologies.
• Execute quality system activities like NCRs, MRB, CAPAs, and risk management including pFMEAs.
• Hire, develop, and manage Quality Engineers to support production priorities.

Requirements

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related)
• 5+ years in Quality Engineering or Manufacturing Engineering in medical devices
• 1+ years leadership experience; people management preferred
• Working knowledge of FDA QSR and ISO 13485 in manufacturing.
• Strong data analysis, problem-solving, and decision-making skills.
• Previous manufacturing engineering, process development, or NPI experience preferred.

Nice to have

• Product Quality Engineering for catheterization or nitinol-based devices.
• High-volume manufacturing and commercial yield ramp experience.
• Inspection systems, destructive testing, statistical sampling.
• Lean/Six Sigma application, CQE certification.
• Data systems like PowerBI/Tableau, statistical analysis, DOE.

Culture & Benefits

• Collaborative teamwork environment with constant learning and performance rewards.
• Generous benefits: medical/dental/vision/life/AD&D/disability insurance, 401(k) match.
• Paid parental leave, 11 company holidays, 15+ days vacation (increases with tenure), paid sick time.
• Business travel 0-10%.