The Fountain Group
Overview
Quality Engineer – North Chicago, IL Pay: $57–61/hr |
Duration:
6 months (with potential to extend or convert based on performance and budget) The Fountain Group is seeking a
Quality Engineer
in North Chicago, IL for a promient client of ours. This position will support design transfer, change management, and compliance activities for medical devices and combination products (infusion pumps, tubing, pre-filled syringes, autoinjectors, eyecare, aesthetics devices, etc.). This role ensures adherence to quality systems, regulatory requirements, and corporate policies. Responsibilities
Lead quality and compliance aspects of design transfer and on-market change management. Ensure design control documentation, risk management, and change control compliance. Support regulatory inspections, internal audits, and act as QA subject matter expert. Collaborate cross-functionally with suppliers, contract manufacturers, and internal teams. Drive process improvements, CAPAs, NCRs, and change plan investigations. Qualifications
Bachelor’s in science, engineering, or related field is required (advanced degree/ASQ certification preferred). 8+ years in medical device industry; 5+ years in Quality Assurance is required. Must have strong knowledge of ISO 13485, ISO 14971, 21 CFR 4/820, MDR/MDD. Experience with combination products preferred.
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Quality Engineer – North Chicago, IL Pay: $57–61/hr |
Duration:
6 months (with potential to extend or convert based on performance and budget) The Fountain Group is seeking a
Quality Engineer
in North Chicago, IL for a promient client of ours. This position will support design transfer, change management, and compliance activities for medical devices and combination products (infusion pumps, tubing, pre-filled syringes, autoinjectors, eyecare, aesthetics devices, etc.). This role ensures adherence to quality systems, regulatory requirements, and corporate policies. Responsibilities
Lead quality and compliance aspects of design transfer and on-market change management. Ensure design control documentation, risk management, and change control compliance. Support regulatory inspections, internal audits, and act as QA subject matter expert. Collaborate cross-functionally with suppliers, contract manufacturers, and internal teams. Drive process improvements, CAPAs, NCRs, and change plan investigations. Qualifications
Bachelor’s in science, engineering, or related field is required (advanced degree/ASQ certification preferred). 8+ years in medical device industry; 5+ years in Quality Assurance is required. Must have strong knowledge of ISO 13485, ISO 14971, 21 CFR 4/820, MDR/MDD. Experience with combination products preferred.
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