Quality Engineer

Location :
Chicago, IL or Northfield, IL (Hybrid)

Employment Type

:
Contract (W2 / 1099)

We are seeking an experienced Quality Engineer to support a leading medical supply organization with cross-divisional quality and remediation initiatives. This role will focus on Design Controls, DHF remediation, Risk Management, CAPA activities, and Quality System compliance within a regulated medical device environment.

The ideal candidate will have strong experience supporting Design History Files (DHF), Device Master Records (DMR), quality system remediation, and regulatory compliance activities in accordance with FDA and ISO requirements.

• Support and execute Design Control activities in accordance with 21 CFR 820.30 and ISO 13485
• Lead and support DHF remediation projects, including gap assessments, traceability reviews, and documentation updates
• Review, update, and maintain DHFs, DMRs, Risk Management Files, Design Review documentation, and Requirements Traceability Matrices (RTMs)
• Partner with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality teams to ensure compliant product development activities
• Support FDA, ISO, and external audits, including preparation and remediation efforts
• Drive CAPA activities related to design, product quality, and compliance issues
• Participate in root cause investigations, risk assessments, and continuous improvement initiatives
• Ensure design changes are properly evaluated, documented, and processed through change control systems
• Support quality system improvements resulting from audit findings, compliance initiatives, and business growth activities
• Generate and maintain product specifications, technical files, and quality documentation

• 3–5+ years of experience as a Quality Engineer, Design Quality Engineer, or Quality Systems Engineer
• Experience with in Medical Device, Pharmaceutical, OTC, Cosmetic, or regulated healthcare manufacturing environments
• Strong knowledge of 21 CFR Part 820 and/or ISO 13485 requirements
• Hands‑on experience supporting DMRs, DHFs, Design Controls, and Risk Management activities
• Experience with CAPA investigations and quality system processes
• Experience supporting remediation projects and documentation updates
  
  Strong problem‑solving, communication, and organizational skills
• Ability to work independently and collaborate across multiple functions

• Experience with Reliance or similar QMS platforms
• Experience with DHF remediation and audit readiness initiatives
• Knowledge of ISO 14971 Risk Management processes
• Experience supporting FDA inspections and ISO audits
• Experience with in medical device manufacturing environments

Compensation is based on experience.

Benefits will be provided by the hiring client in accordance with their policies.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background checks may be conducted in accordance with applicable laws.

Applicants must be authorized to work in the United States.