Engr 3, Quality (Quality Engineer)
Must Have
- Design Controls
- FDA Quality System Regulation
- Proactive Problem Solving
- Process Validation
1. Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools.
2. Proven problem-solving skills.
3. Makes measurable improvements to processes and procedures.
4. Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
5. Acts as a team member representing Quality on new product development and sustaining engineering projects.
6. Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc.
7. Assists 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).
8. May perform other duties as required. Education and Experience:
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 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.
• Able to revise policies and procedures
• Able to make presentations
• Can independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with software systems utilized in the Quality Systems is desirable.
• Must have knowledge/specialization in one or more of the following areas:
o Acceptance sampling theory and application
o Statistical process control methods and application
o Measurement system/test method knowledge and analysis
o Quality planning
o Failure analysis investigation
o Design of Experiments
o Process mapping and value stream analysis
o Hypothesis testing
o Descriptive statistics
o Process capability analysis
o Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
o Risk Management
o Supplier quality management
o Auditing
o Design/development tools
o Process validation
o Software validation
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