Role : Quality Engineer I

Location : Des Plaines, IL

Duration : 12 Months

Shift Timings : 8am to 5 pm

Job Duties:

• The Quality Engineer, Quality Assurance will be responsible for supporting cross functional teams through changes to on-market product design and manufacturing processes.
• Additionally, the candidate may provide support for other design and compliance projects within the division.
• General : The candidate must be able to provide solutions to a wide range of difficult problems, while ensuring that those solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
• They will serve as the QA team member on cross-functional project teams; must be able to interact effectively with employees, manager, and cross-functional peers.
• They must be able to communicate confidently and effectively with management, peers, and key stakeholders.
• Design Control: The candidate will guide and influence on-market product cross-functional teams through design, validation, and regulatory compliance and assure robust product vs. customer requirements.
• The candidate should be able to assess manufacturing process changes and the impact on the product.
• They should be able to formulate appropriate reasons and justifications for changes, including assessment of crucial parameters and other affected systems/products.
• They should possess a thorough understanding of the design control lifecycle, including design inputs, verification, validation, and commercialization.
• Knowledge of application of IVDR standards to the design process is a plus.
• Quality System: The candidate maintains and ensures compliance to the quality system that is appropriate for the unit specific medical device(s) designed or manufactured.
• They must be able to ensure compliance to, and be able to demonstrate, knowledge of site level policies and procedures.
• Education : Bachelor's degree in Life Science, Engineering, or closely related discipline.
• At least 5 years work experience in Quality or related field experience (diagnostic quality, technical area, etc); Less experience may be appropriate with an advanced degree.
• Preferred experience in the Healthcare industry; preferred experience with instrument systems and associated software.