Quality Engineer III

Responsibilities

• Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools.
• Proven problem-solving skills.
• Makes measurable improvements to Client processes and procedures.
• Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
• Acts as a team member representing Quality on new product development and sustaining engineering projects.
• Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc.
• Affords assistance with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training).

Requirements

• 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.
• 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 Client products.
• Applied knowledge of Corporate and/or Unit requirement.
• Able to contribute to the completion of specific programs and projects.
• Able to ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Able to revise policies and procedures.
• Able to make presentations.
• Able to independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Able to design and perform development working independently within defined parameters with minimal supervision required.
• Experience with Client software systems utilized in the Quality Systems is desirable.
• Acceptance sampling theory and application.
• Statistical process control methods and application.
• Measurement system/test method knowledge and analysis.
• 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.