Full-Time

Senior Quality Engineer

Confirmed live in the last 24 hours

Element Biosciences

Element Biosciences

201-500 employees

Next-generation sequencing technology provider

Biotechnology
Healthcare

Compensation Overview

$97k - $118kAnnually

+ Stock Options + Bonus

Senior

San Diego, CA, USA

Category
QA & Testing
Quality Assurance
Required Skills
Data Analysis
Requirements
  • Bachelors degree in Engineering, Biology, Molecular Biology, Microbiology, or related science field (an equivalent combination of experience and education may be considered)
  • A minimum of 5 years’ experience, preferably in the life sciences industry or fast pace start up
  • Experience with ISO9001, ISO13485, 21CFR820, 21CFR 211, or other regulated industries is strongly preferred
  • Ability to understand quality systems and implement risk-based, systemic changes to enhance product quality and business efficiency in a scalable manner
  • Strong interpersonal skills with the ability to collaborate closely with suppliers and with internal Production and Operations staff of varying levels to drive Quality System improvements and deliver necessary compliance requirements
  • Demonstrates an ability to work independently and as part of a team
  • Self-motivated and able to organize and prioritize multiple tasks
  • Strong inclination and passion for continuous improvement
  • Strong analytical skills, reporting, and data analysis are strongly preferred
  • Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success
  • Experience with electronic Quality Management System and manufacturing-related business systems, like ERP and MES, is preferred
  • ISO13485 Lead Auditor certification and ASQ CQE certification is a plus
Responsibilities
  • Supports all aspects of Quality System for on-market products, including Non-Conformance Reports, Corrective and Preventative Actions, Complaint Investigations, Change Management, Risk Assessments, and support of internal and/or external audits
  • Provides quality support on internal failure investigations and leads / facilitates supplier investigations, ensuring corrective and preventive actions are effective and implemented in a timely manner
  • Provides quality input on internal and external test method / component / equipment qualifications, including review of test plans / protocols and reports, guidance on inspection requirements and sampling plans, and risk assessments
  • Establish effective Quality Procedures associated to the Quality Management System
  • Responsible for establishing and continuous improvement of Quality Systems processes through collection of customer feedback, establishment of metrics, data trending
  • Provides Quality Engineering expertise, guidance, coaching for Manufacturing Operations, Supplier Quality, Product Quality, and New Product Development as needed

Element Biosciences specializes in next-generation sequencing (NGS) technology, primarily through its product, the AVITI System. This compact benchtop system provides high-quality DNA sequencing at a low cost, charging only $1 per million reads, which is significantly less than the industry average. The AVITI System is designed to deliver industry-leading accuracy, allowing users, including academic researchers and pharmaceutical companies, to maximize their resources. Element Biosciences differentiates itself from competitors by offering a cost-effective solution and establishing partnerships with other biotech firms, such as QIAGEN, to provide complete NGS workflows. Additionally, the company runs the 2023 AVITI for All Grant program, which offers free sequencing for various applications, further promoting research and demonstrating the AVITI System's capabilities. The goal of Element Biosciences is to make high-quality sequencing accessible and affordable for a wide range of users.

Company Stage

Series D

Total Funding

$659.5M

Headquarters

San Diego, California

Founded

2017

Growth & Insights
Headcount

6 month growth

10%

1 year growth

17%

2 year growth

28%
Simplify Jobs

Simplify's Take

What believers are saying

  • Element Biosciences' recent $277M Series D funding round underscores strong investor confidence and provides substantial resources for growth and innovation.
  • The rapid growth in AVITI System installations, from 20 to over 150 units in a year, indicates strong market adoption and customer satisfaction.
  • The introduction of AVITI24 and Trinity platforms positions Element Biosciences at the forefront of multi-omics and targeted sequencing, potentially revolutionizing research capabilities.

What critics are saying

  • The competitive landscape in NGS technology is intense, with established players potentially overshadowing Element Biosciences' market presence.
  • Rapid expansion and scaling may strain operational capabilities and affect product quality or customer support.

What makes Element Biosciences unique

  • Element Biosciences offers the AVITI System, which provides high-quality sequencing at a significantly lower cost than industry standards, making advanced sequencing more accessible.
  • Strategic partnerships with companies like QIAGEN and Twist Bioscience enhance the AVITI System's capabilities, offering comprehensive NGS workflows and exome sequencing solutions.
  • The company's grant program, AVITI for All, democratizes access to sequencing technology, showcasing the system's capabilities and fostering innovation across various fields.

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Benefits

100% company-paid medical, dental, & vision coverage

Flexible spending & health savings accounts

Premier mental health care

401(k) with immediately vested 4% company match

Company-paid Life and AD&D insurance

Stock option grants

Flexible time off

10 paid annual holidays

8-weeks paid parental leave