Senior Quality Engineer, Reagents

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Fremont, CA, USA
In-Office
Biotech
The Role

Rapidly Growing Life Sciences Technology Company

Ultima Genomics is 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

At Ultima Genomics, your base pay is one part of your total compensation package. This role pays between $100,000 and $120,000, if performed in California, and your actual base pay will depend on your skills, qualifications, experience, and location.  Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.  This role is also eligible for a competitive benefits package that includes: medical, dental, vision, life, and disability insurance; 401(k) retirement plan; flexible spending & health savings account; paid holidays; paid time off; employee assistance program; and other company benefits.

Ultima Genomics is proud to be an equal opportunity workplace and is an affirmative action employer. We provide equal employment opportunity for all applicants and employees. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, gender expression, national origin, ancestry, citizenship, age, physical or mental disability, military or veteran status, marital status, domestic partner status, sexual orientation, genetic information, or any other basis protected by applicable laws. See also Ultima Genomics’ EEO Policy and Know Your Rights. If you have a disability or special need that requires accommodation, please let us know by contacting [email protected].

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The Company
HQ: Newark, CA
303 Employees
Year Founded: 2016

What We Do

Ultima Genomics is unleashing the power of genomics at scale. Our mission is to continuously drive the scale of genomic information to enable unprecedented advances in biology and improvements in human health. With humanity on the cusp of a biological revolution, there is a virtually endless need for more genomic information to address biology’s complexity and dynamic change—and a further need to challenge conventional next-generation sequencing technologies. Ultima’s revolutionary new sequencing architecture drives down the costs of sequencing to help overcome the tradeoffs that scientists and clinicians are forced to make between the breadth, depth, and frequency with which they use genomic information. The new sequencing architecture was designed to scale far beyond conventional sequencing technologies, lower the cost of genomic information and catalyze the next phase of genomics in the 21st century.

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