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 deliverables
• Ensure Design History File (DHF) completeness, structure, and traceability across all elements
• Lead design control execution, including documentation, change control, and traceability linkages
• Evaluate and assess impact of design changes on product safety, efficacy, and regulatory compliance
• Ensure alignment with device, drug, and biologics regulations (as applicable for combination products)
• Apply risk management methodologies (e.g., ISO 14971) to product development
• Partner cross-functionally in a global team environment

Must-Have Skills & Experience

• Deep expertise in:
  • DHF structure & traceability
  • Medical devices & combination product regulations
  • Design controls (FDA, ISO standards)
• Strong understanding of:
  • Verification & Validation (V&V) strategies
  • Requirements definition and specification development
• Hands-on experience with:
  • Risk management frameworks
  • Design change control processes
• 5+ years total experience, including:
  • 3+ years in Device Design Quality Assurance

Nice-to-Have Differentiators

• Systems Engineering background
• Experience 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 products
• Can connect requirements risk verification validation DHF traceability seamlessly
• Comfortable acting as the quality authority in cross-functional discussions
• Demonstrates independent ownership but collaborates effectively across global teams
• Experienced in regulatory audits, compliance reviews, or submissions support
• Brings a systems-thinking mindset (can see the full product lifecycle vs. siloed activities)

Work Environment & Culture

• Hybrid of independent work + collaborative team engagement
• Standard 40-hour workweek with flexible scheduling around core hours
• Occasional 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.
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.
>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.