Quality Engineer III (Medical Devices)

TL;DR

Quality Engineer III (Medical Devices): Support manufacturing operations and production lines tackling complex, ambiguous quality challenges with high autonomy. Focus on leading root cause investigations, improving inspection strategies and process monitoring, and applying Lean/Six Sigma methodologies to enhance capability and reduce waste.

Location: Alameda, CA (onsite)

Salary: $109,000–$152,000/year

Company

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

What you will do

• Provide Quality Engineering support for assigned products and production lines.
• Partner with Production, Manufacturing Engineering, and Industrial Engineering to build quality into manufacturing processes.
• Lead root cause investigations using structured tools like 5 Why, Fishbone, DOE, and regression analysis.
• Monitor manufacturing quality performance including yield, scrap, and process capability.
• Improve inspection strategies, test methods, sampling plans, and acceptance criteria.
• Execute quality system activities such as NCRs, MRB, CAPAs, and pFMEA maintenance.
• Support commercial ramp-up, material/process changes, and site transfers.

Requirements

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related)
• 3+ years in Quality or Manufacturing Engineering in medical device industry
• Experience supporting manufacturing operations, process development, or NPI
• Strong problem solving, data analysis, and decision-making skills
• Excellent verbal, written, and interpersonal communication skills

Nice to have

• Familiarity with QSR, ISO, and regulations
• Experience with high volume manufacturing and yield ramp
• Leading projects or cross-functional coordination
• Background in inspection systems, destructive testing, statistical sampling

Culture & Benefits

• Collaborative teamwork environment with constant learning and performance rewards.
• Comprehensive benefits: medical, dental, vision, life, AD&D, short/long-term disability insurance.
• 401(k) with employer match, paid parental leave, 11 paid holidays, 15+ days vacation increasing with tenure, paid sick time.