Quality Engineer
Domain
Medical diagnostics, CLIA laboratory, Life Sciences, Genetic testing
Seniority
Mid-Senior level (6+ years total experience, 3+ in quality)
Required skills
B.S. in science/engineering, Audit experience (internal, third-party, regulatory), CAPA/Deviation/Change Request management, Statistical analysis (AQL, hypothesis testing), Knowledge of CLIA/CAP, ISO 13485, FDA QSR (21 CFR 820), HIPAA, Technical writing, MS Office
Preferred skills
CQE certification, Hands-on experience with DNA Isolation, PCR, Cell Culture, Sequencing, Bioinformatics
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