Senior Quality Engineer
Updated on 5/19/2023
San Diego, CA, USA
Experience Level
  • Experience with ISO9001, ISO13485, 21CFR820, 21CFR 211, or other regulated industries is strongly preferred
  • Experience with using Root Cause Analysis methods and tools (i.e., 8D, 5Whys, Ishikawa, Is/Is Not, etc.)
  • Experience with electronic Quality Management System strongly preferred
  • Experience with pFMEA development and using risk management tools
  • Experience with Design Control is a strong plus
  • Well versed in quality systems processes and keen on continuous improvement to support the production process and improve business efficiency
  • Strong interpersonal skills and ability to collaborate closely with R&D and Operations staff to drive Quality System utilization and meeting necessary business and compliance requirements
  • Demonstrates an ability to work independently and as part of a team
  • Self-motivated and able to organize and prioritize multiple tasks
  • Experience with manufacturing-related business systems, like ERP and MES, is preferred
  • Strong analytical skills, reporting, and data analysis are strong preferred
  • ISO13485 Lead Auditor certification is a strong plus
  • Ability to work in a fast-paced and technically challenging environment where drive is critical to success
  • ASQ CQA certification a plus
  • S./B.A. degree in Engineering, scientific discipline, or equivalent combination of experience and education may be considered
  • A minimum of 5 years of experience, preferably in the life sciences industry
  • Must be able to lift 15 pounds
  • Lead and support component and product failure investigations, ensuring mitigations and corrective actions are implemented in a timely manner
  • Manage the Supplier Corrective Action Request (SCAR) and other supplier quality related issues, including track and trending of defects
  • Support the Change Management process as it applies to design changes and process changes
  • Maintain effective Quality Procedures associated to the Quality Management System
  • Monitor Quality systems processes through KPIs and Management Review
  • Responsible for continuous improvement of Quality Systems processes through collection of customer feedback and data trending
  • Supports incoming inspection, Quality Control, and quality release of products
  • Provides Quality Systems guidance and training
  • Responsible for Quality Systems development and maintenance: Complaints, NCR, CAPA, Change Control, Risk Management, and Audits
  • Plan and perform third-party audits and internal audits, as needed
  • Other duties as assigned
Element Biosciences

201-500 employees

Genetic analysis biotechnology research
Company Overview
Element Bioscience’s mission to empower the scientific community with more freedom and flexibility to accelerate collective impact on humanity. The company has developed a modular and high performing DNA sequencing platform that delivers quality data, workflow flexibility and makes next-generation sequencing technology more accessible.
  • 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
Company Core Values
  • Laugh often
  • Be bold
  • Win together
  • Be curious
  • Inspire others
  • Think big