We are hiring a Quality Engineering Manager for an In-Vitro Diagnostics company in San Diego, CA. This is an on-site role with direct-reports.
Background Requirements:
Bachelor's degree or equivalent experience required; bioengineering, biochemistry, chemistry, molecular biology, or related technical science discipline required. Advanced degree preferred.
ASQ Certifications for Certified Quality Engineer (CQE), Certified Medical Device Auditor (CMDA), Six sigma black belt, or Certified Quality Manager (CQM) preferred.
5+ years of experience in an in vitro diagnostics experience within risk management, problem solving, and root cause analysis methodologies required.
5+ years' experience supervising or managing an operational team required, including responsibility to staffing management and development, budget management and compliance with policies & regulations.
Technical writing experience required.
Experience in IVD systems development (integrating reagent, instrumentation, and software) preferred.
Experience in design and development, technology transfer, risk management, verification and validation, statistical analysis techniques required.
Experience with data collection, data analysis/evaluation, and scientific method required.