Senior Quality Engineer, Reagents Fremont, California

Senior Quality Engineer, Reagents
Fremont, California, United States
Rapidly Growing Life Sciences Technology Company

a rapidly growing company that is developing ground-breaking genomics technologies. Our mission is to continuously drive the scale of genomic information to enable unprecedented advances in biology and improvements in human health. We have developed a foundational new approach to sequencing at scale that overcomes limitations due to the high costs of current technologies. We are well-funded and have raised approximately $600 million from global top-tier investors.

Our team brings together unique and diverse expertise across multiple disciplines, from healthcare and life sciences, to engineering, to technology and software and beyond. We are a collaborative group, including successful entrepreneurs, chemists, hardware and software engineers, genomics and biotechnology experts, molecular and computational biologists, software and algorithm experts, and operations and commercial leaders. Join us to develop and commercialize technologies that unleash the power of genomics at scale and empower the future of human health.

We are looking for a highly motivated Senior Quality Engineer, Reagents to join our team!

How You’ll Contribute

Assess quality gaps within the consumables production workflows and assist in implementing the necessary solutions that will satisfy ISO 13485 requirements
Assist in authoring and/or revising documentation such as batch records, work instructions and SOPs to satisfy ISO 13485 requirements
Be responsible and accountable for the quality of products through testing, and continuously find ways to improve processes to ensure delivered products meet expected quality and performance standards
Maintain calibration and preventative maintenance records for equipment and systems as well as records related to reagent quality
Lead projects focused on reducing non-conforming material and rework
Lead or participate in investigations and troubleshooting efforts related to quality of raw materials and finished goods
Track and implement plans to correct reported quality issues
Assist in quality aspects required for new product introduction
Other duties as assigned
Qualifications, Skills, Knowledge & Abilities

BS in Biomedical Engineering, Bioengineering, Chemical Engineering, Materials Science, or closely related field and 5+ years 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 such as fishbone diagrams, FMEA, process capability analysis, SPC
Skilled in applying a variety of measurement and inspection techniques
Experience in authoring quality documentation
Excellent organizational, communication, time management and analytical skills
Self-motivated, detail-oriented, willing to learn, and interested in working in a team environment