US-CA-SanDiego: Quality Assurance Engineer
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please visit http://sqa.fyicenter.com
Quality Assurance Engineer
Perform root cause analysis using statistical analysis and DOE tools. Review, update, and optimize assay release testing processes and procedures. Develop, implement, and perform validations, material qualifications, and verification activities. Develop, maintain, and use SPC to analyze and improve MFG and quality control processes.
* BS/BA degree in Chemical, Biomedical engineering, Engineering, Chemisty, Biochemistry or equivalent.
* Minimum of 3 years validation experience in a FDA regulated Medical Device, Biotech, or Pharmaceutical organization.
* Knowledge of GMP, QSR/ISO 13485/ISO 14971 regulations in Medical Devices.
* Strong knowledge of theory and principles of statistics and statistical process control.
* Quality-oriented, high attention to detail, and organized.
* Experience working in high performance teams.
* Strong written and verbal skills in documentation, communication, and teamwork.
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Team SQAFYI - Software QA Resource FYI