Senior Quality Systems Manager, Medical Devices

GForce Life Sciences; Chicago (IL); On-site; USD 130,000 - 150,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k

Job summary

GForce Life Sciences seeks an experienced Quality Manager to oversee the QMS and drive continuous improvement for medical devices. You will own the QMS, manage CAPAs, vendor quality, and participate in audits with a hands-on, cross-functional approach.

The role requires expertise in ISO 13485 and FDA 21 CFR 820, plus proven ability to lead regulatory inspections and maintain lifecycle quality documentation. Onsite Chicago area employees preferred.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline.
• 7+ years in Quality Assurance, Quality Systems, or Quality Engineering, including 5+ years in medical device/combination product.
• Strong working knowledge of ISO 13485 and FDA 21 CFR 820 (QMSR).
• Experience maintaining, improving, or managing a regulated Quality Management System.
• Hands-on CAPA, nonconformance management, change control, document control, internal audits, and supplier quality processes.
• Experience owning or administering an electronic Quality Management System (eQMS) with validated software.

Responsibilities

• Own and manage the Quality Management System (QMS) including eQMS administration and document control.
• Lead CAPA investigations, root cause analysis, corrective actions, and effectiveness verification.
• Oversee supplier qualification, evaluation, monitoring, and supplier quality management activities.
• Coordinate internal and external audits, including ISO certification and regulatory inspections; ensure inspection readiness.
• Collaborate with cross-functional teams to embed quality requirements in development and testing activities.

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline

Job description

GForce Life Sciences seeks an experienced Quality Manager to oversee the QMS and drive continuous improvement for medical devices. You will own the QMS, manage CAPAs, vendor quality, and participate in audits with a hands-on, cross-functional approach.

The role requires expertise in ISO 13485 and FDA 21 CFR 820, plus proven ability to lead regulatory inspections and maintain lifecycle quality documentation. Onsite Chicago area employees preferred.