Quality Lead

Position: Quality LeadLocation: Waukegan, IL 60085Duration: 7 MonthsJob Type: Temporary Assignment Work Type: HybridPay Rate: $90.00-$97.00/hrOverview: TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This Client is mission is to discover and deliver innovative medicines and solutions that address complex health issues and enhance people’s lives.Job ResponsibilitesServes 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.Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations.Responsible for compliance with company policies and procedures.Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.Assess the impact of a change on the safety, efficacy of the combination product/device.Analyze and justify the impact on cumulative changes.Years of experience/education and/or certifications required:Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required.5+ years of total combined experience. At least 3 years in Device Design Quality AssuranceWhat are the top 3-5 skills requirements should this person have?Deep understanding of DHF structure and traceability between DHF elements.Knowledge and a comprehensive understanding of combination products, medical devices and design controls.Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control.Well-versed in risk management methodologies and their application.Work independently and in a global team environment, and with all levels of personnel within the organization.What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?Examples: Bachelor of Science; 4-year pharma, health care, or regulated industry1. Systems Engineering experience2. Relational database experience.TekWissen® Group is an equal opportunity employer supporting workforce diversity.