General Summary
As a Quality Engineer III, you will support manufacturing operations and production lines for a range of medical devices. This role requires you to tackle complex, ambiguous quality challenges in our manufacturing processes with a high degree of autonomy, applying advanced problem solving and thoughtful decision-making from early commercial ramp through mature production. Your work will directly impact patient safety and product performance, while influencing cross functional decisions, leading investigations, proactively identifying risk, and helping shape robust, scalable quality systems that support both innovation and compliance. You will partner closely with Manufacturing Engineering, Production, and Industrial Engineering to ensure quality is built into every stage of the manufacturing process.
Specific Duties and Responsibilities
• Provide Quality Engineering support for assigned products and production lines
• Act as a quality partner to Production, Manufacturing Engineering, and Industrial Engineering
• Lead root cause investigations using structured problem solving tools (5 Why, Fishbone, DOE, regression analysis)
• Support monitoring of manufacturing quality performance, including yield, scrap, and process capability
• Improve inspection strategies, including in process and final inspection, destructive testing, sampling plans, and acceptance criteria
• Lead continuous improvement of inspection systems, test methods, process monitoring, and other quality tools
• Apply Lean and Six Sigma methodologies to reduce waste and improve process capability
• Execute quality system activities within Operations, including NCRs, MRB, CAPAs, control chart investigations, and effectiveness verification
• Maintain pFMEAs, ensuring risks are mitigated through appropriate controls and monitoring
• Support early commercial ramp-up, material or process changes, and site transfers
Position Qualifications
Minimum education and experience:
• Bachelor's degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred)
• 3+ years of experience in Quality Engineering or Manufacturing Engineering within the 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
Preferred Experience:
• Familiarity with QSR, ISO, and other applicable regulations and laws
• Experience supporting high volume manufacturing and early commercial yield ramp
• Experience leading projects or coordinating cross functional project activities
• Background in inspection systems, destructive testing, and statistical sampling methodsVersatility, flexibility, and willingness to work within a dynamic environment
Working Conditions
• General office, laboratory, and cleanroom environments
• Requires some lifting and moving of up to 25 pounds
• The employee is frequently required to stand, walk, sit, and reach with hands and arms,
and to use a computer, sitting for extended periods. Specific vision abilities required by
this job includes the ability to read, close vision, distance vision, color vision, peripheral
vision, and depth perception.
• Alameda, CA
• Starting Base Salary is $109,000/year to $152,000/year
The above statements are intended to describe the general nature and level of work being
performed by people assigned to this classification. They are not intended to be construed as an
exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
What We Offer
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
