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Katalyst Healthcares & Life Sciences | North Chicago, Illinois, United States | Posted May 05, 2026
Position Overview
Roles & Responsibilities:
- Serves as the primary quality lead for project activities to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of the project.
- Assures proper integration and support of device regulations, drug regulations, and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures.
- Ensures design control documentation (Traceability/Linkages) & design change control requirements are met. Assesses the impact of a change on the safety, efficacy of the combination product/device. Analyzes and justifies the impact on cumulative changes.
Education & Experience:
- 5+ years of total combined experience. At least 3 years in Device Design Quality Assurance
- What are the top 3-5 skills requirements should this person hav...