Quality Engineer I
Location
Des Plaines, IL
Level
Entry-Level
Department
MedTech
Type
Salary
Job Description
Posted on:
2025-07-18
Responsibilities
- Support cross-functional project teams in design and compliance projects.
- Provide solutions to complex problems while ensuring compliance and practicality.
- Guide teams through design, validation, and regulatory compliance.
- Assess manufacturing process changes and their impact on products.
- Maintain and ensure compliance with the quality system.
- Communicate effectively with management, peers, and stakeholders.
- Demonstrate knowledge of the design control lifecycle and IVDR standards.
Job Requirements
- Bachelor's degree in Life Science, Engineering, or a related discipline.
- At least 5 years of work experience in Quality or a related field.
- Preferred experience in the Healthcare industry, particularly with assay development.
- Ability to communicate confidently and effectively.
- Understanding of design inputs, verification, validation, and commercialization.
- Knowledge of site-level policies and procedures.
- Ability to formulate justifications for design changes.
