Engr 3, Quality (Quality Engineer)

Must Have

• Design Controls
• FDA Quality System Regulation
• Proactive Problem Solving
• Process Validation

The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
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