Senior Quality Engineer, Reagents

Job Description

Ultima Genomics is seeking a highly motivated Senior Quality Engineer, Reagents to join their team in Fremont, California. The company is focused on developing ground-breaking genomics technologies to drive the scale of genomic information and improve human health.This role involves:

• Assessing quality gaps within consumables production workflows.
• Implementing solutions to satisfy ISO 13485 requirements.
• Authoring and revising documentation such as batch records and SOPs.
• Being responsible for product quality through testing.
• Improving processes to ensure products meet quality standards.
• Maintaining calibration and preventative maintenance records.
• Leading projects to reduce non-conforming material and rework.
• Participating in investigations related to raw material and finished goods quality.
• Tracking and implementing plans to correct reported quality issues.
• Assisting in quality aspects for new product introduction.

Requirements include:

• BS in Biomedical Engineering, Bioengineering, Chemical Engineering, Materials Science, or a related field.
• 5+ years of experience in reagents or consumables quality.
• Quality systems experience in a manufacturing environment.
• Working knowledge and practical application of ISO 13485 requirements.
• Experience applying quality problem-solving methods.
• Skilled in authoring quality documentation.
• Excellent organizational, communication, time management, and analytical skills.
• Self-motivated, detail-oriented, and willing to learn.

Ultima Genomics offers:

• Competitive benefits package including medical, dental, vision, life, and disability insurance.
• 401(k) retirement plan.
• Flexible spending & health savings account.
• Paid holidays and paid time off.
• Employee assistance program.