Medical Device Quality Engineer

Title: Quality Engineer

Location: Chicago, IL or Northfield, IL

Duration: 6-month contract (potential extensions or hire)

Shift: M-F, 8-5 PM CT

Pay Rate: $44-47/hr

Start date: ASAP

Requirements:

• 2-5 years of experience as a Quality Engineer within medical devices or regulated healthcare manufacturing.
• Strong working knowledge of: Design Controls (21 CFR 820, FDA QSR and ISO 13485).
• Hands‑on experience supporting Device Master Record (DMR) and Design History Files (DHF) maintenance, execution, or remediation.
• Skills: Adaptive, cross-functionally collaborative, strong time management skills, independent, problem solver

Insight Global is seeking an experienced, highly skilled Quality Engineer to support an established medical supply client out of Chicago, IL. The Quality Engineer will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.

Key Responsibilities:

• Support and execute Design Control activities in accordance with 21 CFR 820.30 and ISO 13485, including design planning, design inputs/outputs, verification, validation, and design transfer.
• Lead or contribute to Design History File (DHF) remediation projects, including gap assessments, documentation updates, traceability, and audit readiness.
• Review, update, and maintain quality documentation such as DHFs, Risk Management Files (ISO 14971); Design Review documentation; Requirements traceability matrices (RTMs).
• Partner cross‑functionally with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality to address quality issues and ensure compliant product development.
• Support internal and external audits and inspections (FDA, ISO, notified bodies), including preparation and remediation activities.
• Drive corrective and preventive actions (CAPAs) related to design and product quality issues.
• Participate in root cause investigations, risk assessments, and continuous improvement initiatives tied to design and product lifecycle management.
• Ensure design changes are properly evaluated, documented, and approved per change control processes.
• Support quality system improvement initiatives stemming from FDA audit findings or business growth.