Cincinnati, OH30+ days ago
Strong analytical skills and a working knowledge of problem-solving methodologies • Working knowledge of DFSS techniques, process Improvement techniques, and Lean process improvement techniques • 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development • Fluent in French and English • Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology • Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making • Demonstrates excellent organizational, verbal and written communication skills • Proficient with the MS Office Suite, and statistical software • Must be able to work independently with minimal supervision • Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives. Qualifications • Bachelor's degree in engineering (Electrical/Electronic preferred, others considered Mechanical, Systems, Chemical) • 8 years of experience of working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP.