Quality Engineer I
Location
Des Plaines, IL
Level
Internship
Department
Medical Devices
Type
Salary
Job Description
Posted on:
2025-05-06
Responsibilities
- Act as the Quality Assurance representative on cross-functional project teams to ensure quality standards.
- Lead and support the implementation of design and manufacturing process changes for existing products.
- Provide guidance on design control activities including design inputs, verification, validation, and design transfer.
- Evaluate the impact of manufacturing changes on product performance and regulatory status.
- Support the application of IVDR standards within the design process.
- Collaborate with various teams to ensure adherence to software development procedures and industry regulations.
- Review and approve software development lifecycle deliverables for compliance and quality.
Job Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
- Minimum of 5 years of professional experience in quality assurance or regulatory compliance.
- Preferred background in the healthcare or medical device industry.
- Strong knowledge of design controls and quality systems (QMS).
- Excellent communication skills for collaboration and influencing decision-making.
- Candidates with a Master’s degree and less experience may be considered.
- Experience in assay development or diagnostic quality is a plus.
