Senior Quality Engineer

Typically requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.

Knowledge and Skills :

• Applied knowledge of the FDA medical device quality system regulations and international quality system standards / regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR / IVDR) as it relates to the design and continued support of BD products.
• Applied knowledge of Corporate and / or Unit requirement.
• Able to contribute to the completion of specific programs and projects.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers
• Quality planning
• Failure analysis investigation
• Design of Experiments
• Process mapping and value stream analysis
• Hypothesis testing
• Descriptive statistics
• Process capability analysis
• Basic quality tools : Pareto, box plots, histograms, scatter diagrams, etc.
• Risk Management
• Supplier quality management
• Auditing
• Design / development tools
• Process validation
• Software validation