Quality Lead

TitleQuality LeadDuration8 Months (End of 2026)LocationNorth Chicago, IL 60064 (hybrid but open to remote)Role OverviewServes 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) and 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.QualificationsBachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience.5+ years of total combined experience. At least 3 years in Device Design Quality Assurance.Key SkillsDeep understanding of DHF structure and traceability between DHF elements.Knowledge and comprehensive understanding of combination products, medical devices and design controls.Sound technical understanding of product development and practical experience in design control.Well-versed in risk management methodologies and their application.Ability to work independently and in a global team environment, interacting with all levels of personnel within the organization.Nice to haveBachelor of Science; 4-year pharma, health care, or regulated industry.Systems Engineering experience.Relational database experience.Work Environment & ScheduleCombination of group and individual work. 40-hour work week with start and end times negotiable to maintain overlap with core business hours 8:30 – 4:30 Central. Overtime is possible only in extenuating circumstances and not typically allowed. Hybrid model in lake county includes Tues-Thurs in office; remote work may require one visit to lake county per month.Reason for OpeningSupport of DHF reconfiguration project.J-18808-Ljbffr