Quality Design Manager

Quality Design Manager

The Manager, Design Quality – Lifecycle Management represents Quality Assurance on cross‑functional teams and ensures Quality System requirements are met throughout product transfer, commercialization, and on‑market lifecycle support. The role supports medical devices and combination products, including infusion pumps, tubing systems, pre‑filled syringes, autoinjectors, eyecare products, and aesthetic devices, ensuring compliance with global regulatory and corporate standards.

• Act as the primary QA lead for design transfer activities enabling product launches (internal and external transfers).
• Drive quality and compliance aspects of product transfer and on‑market change management.
• Lead and support lifecycle design change projects following Design Control and Change Control principles.
• Own and execute change plans, including impact assessments, action plans, and closure tracking.
• Ensure design control documentation (traceability, linkages) and change control requirements are met.
• Identify and close gaps in Design History Files (DHF) and Risk Management.
• Support and lead process validation activities (IQ/OQ/PQ/PPQ, TMV).
• Support regulatory inspections and internal audits; serve as QA Subject Matter Expert.
• Mentor and guide product teams through design transfer processes.
• Assist and guide third‑party suppliers through change management strategies.
• Maintain strong relationships with plants, suppliers, contract manufacturers, and affiliates.
• Participate in the development and execution of global Product Quality Assurance strategies.
• Identify gaps in existing processes and lead cross‑functional teams to implement solutions.
• Proactively monitor process effectiveness and quality of project work.
• Write, review, and improve quality policies, procedures, and documentation.
• Lead or participate in investigations related to Change Plans, CAPAs, NCRs, and observations.

• Proficient in Design Control Principles.
• Expertise in Change Control Principles.
• Working knowledge of Medical Devices & Combination Products, including infusion pumps, on‑body injectors, and pre‑filled syringes.
• Understanding of FDA & EU Regulations and applicable international standards.

• Bachelor’s degree in Engineering, Science, or related technical field; advanced degree preferred.
• ASQ certification preferred (CQA, CQE, SSBB, etc.).
• 8+ years in medical device and/or combination product industry.
• 5+ years of Quality Assurance experience.
• Experience with infusion pumps, PFS, autoinjectors, or on‑body injectors preferred.
• Knowledge of regulatory and standards such as ISO, 21 CFR Part 4, 21 CFR Part 820, EU MDD (93/42/EEC) and MDR (2017/745).

The role offers a hybrid work arrangement with 3 days onsite and 2 days working from home, adhering to the hybrid policy. Travel may be required up to 10% of the time, including domestic and international trips for product transportation. The environment is fast‑paced and regulated, requiring adaptability, strategic decision‑making, and strong cross‑functional leadership skills.

Contract position based out of North Chicago, IL.

The pay range for this position is $90.00 - $110.00/hr.

• 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&DD 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.

Final date to receive applications:
This position is anticipated to close on Feb 28, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.