Senior Quality Engineer (Medical Devices)

TL;DR

Senior Quality Engineer (Medical Devices): Support manufacturing operations and production lines for medical devices with an accent on process control, inspection systems, and yield improvements. Focus on leading complex root cause investigations, championing inspection strategies, and applying Lean and Six Sigma methodologies to enhance quality standards.

Location: Alameda, CA (onsite)

Salary: $125,000 to $175,000

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.
• Act as key quality partner to Production, Manufacturing Engineering, and Industrial Engineering.
• Lead root cause investigations using tools like 5 Why, Fishbone, DOE, and regression analysis.
• Monitor manufacturing quality performance including yield, scrap, and process capability.
• Improve inspection strategies, test methods, process monitoring, and digital quality tools.
• Execute quality system activities such as NCRs, MRB, CAPAs, and pFMEAs.

Requirements

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related)
• 5+ years in Quality or Manufacturing Engineering in medical device industry
• Experience supporting manufacturing operations, process development, or NPI.
• Working knowledge of FDA QSR and ISO 13485.
• Strong data analysis, problem-solving, and decision-making skills.

Nice to have

• CQE certification or related training.
• Experience with high volume manufacturing and commercial yield ramp.
• Background in inspection systems, destructive testing, and statistical sampling.
• Experience managing projects or cross-functional activities.
• Measurement System Analysis (MSA) and Six Sigma Black Belt projects.

Culture & Benefits

• Collaborative teamwork environment with constant learning and performance rewards.
• Generous benefits including medical, dental, vision, life insurance, 401(k) with match, paid parental leave, 11 paid holidays, 15+ days vacation increasing with tenure, and paid sick time.
• Business travel 0-10%.