Position Details
Quality Engineer Apply
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Role: Quality Engineer
Location: Des Plaines, IL
Duration: 12 Months
Shift Timings: 8am to 5 pm
Role: Quality Engineer
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 to 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 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 is 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 advanced degree.
- Preferred experience in the Healthcare industry; preferred experience with instrument systems and associated software.
