Job Summary

Quality Systems Engineer

  • Location:
    Costa Mesa, California
  • Job reference:
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A Quality Systems Engineer job near Irvine, CA is available through Modis Engineering. In this role, you will investigate, analyze and troubleshoot quality management system issues through creation and maintenance of quality documents. You will need three or more years’ experience with quality systems in the medical device industry in compliance with CFR 820 Part 820, ISO 13485:2016 and ISO 14971:2007. You will also need professional auditing. The Quality Systems Engineer will collaborate with colleagues and management regarding decisions critical to daily operations and product quality.
Quality Systems Engineer job responsibilities include:

Maintain and update QMS compliance metrics.
Audit QMS to drive compliance, process standardization, waste elimination, and continuous improvement and drive “Zero Findings/Observations” mentality for all QMS audits.
Monitor, communicate and improve key QMS KPI’s, including Internal and Customer Audit results.
Write and/or update QMS procedures to ISO requirements and cGMP regulations based on schedule.
Aide Manufacturing in the development and maintenance of the QMS to drive efficiencies and work with corporate and other manufacturing site to align QMS throughout.


BS Degree in Business or Engineering and ASQ Certification (CQE/CQA/CQT).
Three or more years’ experience in Quality Management System (QMS) activities in the medical device field.
Professional auditing experience and thorough knowledge of CFR 820 Part 820, ISO 13485:2016 and ISO 14971:2007.
Experience with project management techniques such as MS Projects.

If you are interested in the Quality Systems Engineer job near Irvine, CA please click APPLY NOW. For other opportunities, available at Modis please visit us at .

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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