Quality Assurance Engineer

1 week ago


Hazelwood, Missouri, United States bioMerieux Inc. Full time
Job Summary

We are seeking a highly skilled Quality Assurance Engineer to join our team in Hazelwood, MO. As a key member of our quality assurance team, you will be responsible for ensuring the development, manufacturing, and delivery of our products meet established procedures.

Key Responsibilities
  • Participate in regulatory inspections, audits, and investigations to ensure compliance with FDA and international regulations.
  • Resolve and trend department deviations, ensuring all records comply with quality procedures.
  • Provide periodic trend reporting and support risk management activities.
  • Evaluate incoming QC and in-process materials, ensuring their disposition meets site and regulatory requirements.
  • Review and approve validations, verifications, qualifications, and technical reports.
  • Participate in site CAPA activities, including root cause analysis and implementation of corrective actions.
Requirements
  • Bachelor's degree in a scientific field and 3+ years of related experience in quality engineering.
  • Certification in quality engineering is highly desired.
  • Strong computer skills, including Microsoft Office.
  • Expert knowledge of domestic and international regulations and industry standards.
About Us

bioMerieux Inc. is a world leader in in vitro diagnostics, providing diagnostic solutions that determine disease and contamination sources to improve patient health and consumer safety.

We have over 6,200 team members across 11 sites or subsidiaries in North America.

As a family-owned global company, we offer a human-centered culture and a long-term vision.



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