Design Quality Engineer

Role Summary: Design Quality Engineer (Quality Assurance Specialist) This position serves as the quality lead for device/combination product development projects, ensuring design control, regulatory compliance, and DHF integrity across the full product lifecycle. Core Responsibilities Act as the primary quality representative for project teams, driving on-time and compliant deliverablesEnsure Design History File (DHF) completeness, structure, and traceability across all elementsLead design control execution, including documentation, change control, and traceability linkagesEvaluate and assess impact of design changes on product safety, efficacy, and regulatory complianceEnsure alignment with device, drug, and biologics regulations (as applicable for combination products)Apply risk management methodologies (e.g., ISO 14971) to product developmentPartner cross-functionally in a global team environment Must-Have Skills & Experience Deep expertise in:DHF structure & traceabilityMedical devices & combination product regulationsDesign controls (FDA, ISO standards)Strong understanding of:Verification & Validation (V&V) strategiesRequirements definition and specification developmentHands-on experience with:Risk management frameworksDesign change control processes5+ years total experience, including:3+ years in Device Design Quality Assurance Nice-to-Have Differentiators Systems Engineering backgroundExperience with relational databases (useful for traceability, DHF systems, PLM tools) Ideal Candidate Profile (What “Strong Fit” Looks Like) Has worked on end-to-end product development within medical devices or combination productsCan connect requirements → risk → verification → validation → DHF traceability seamlesslyComfortable acting as the quality authority in cross-functional discussionsDemonstrates independent ownership but collaborates effectively across global teamsExperienced in regulatory audits, compliance reviews, or submissions supportBrings a systems-thinking mindset (can see the full product lifecycle vs. siloed activities) Work Environment & Culture Hybrid of independent work + collaborative team engagementStandard 40-hour workweek with flexible scheduling around core hoursOccasional overtime during critical project needs Job Type & Location This is a Contract position based out of North Chicago, IL. Pay And Benefits The pay range for this position is $75.00 - $82.00/hr. Requirements Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in North Chicago,IL. Application Deadline This position is anticipated to close on May 13, 2026.h4>About TEKsystems:We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. About TEKsystems And TEKsystems Global Services We’re a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We’re a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We’re strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We’re building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.