Quality Assurance - Engineer 3

Only on W2 - No C2C Locals Only - Onsite role in Irvine, CA Contract Duration: 11 months contract BEL - Quality Assurance - Engineer 3 Technical Skills Must Have • Data driven. • Strong proficiency in Excel, Power Data driven • Strong proficiency in Excel, Power BI and creating dashboards. • Independent learner. • Focused on driving results and outcomes. Nice To Have • Experience with ETQ Quality Management Systems • Trackwise QMS system is a plus, Bachelor of Science in Engineering, Computer Science, Health Sciences or equivalent work experience Job Description Responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective. Generally matched to Quality Assurance in surveys. • Preferred Bachelor's degree in Engineering, Computer Science, Heath Science • Minimum of 2 years experience in Medical Device, Life Sciences or Healthcare industry • Expertise in extracting, filtering, validating and downloading data from Power BI • Expertise in manipulating, and analyzing large datasets using advanced excel functions and formulas (VLOOKUP, pivot tables, conditional formulas) • Preferred experience with ETQ Quality Management System • Experience in the post-market surveillance area (review of data and relationship to complaints) • Understand the importance of quality compliance with medical device industry data. • Knowledge of applicable FDA regulations for medical device industry (CFR, ISO standards) • Experience in Trackwise QMS a plus • Needs to be a quick learner. Used to working in a tight deadline environment. Highly organized. • Usage of Power Point, Excel, Word • Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills • Strict attention to detail