Senior Quality Auditor, Medical Devices & Diagnostics

Thornton Tomasetti; Lake Forest (IL); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

Career development

Free medical coverage

Retirement plan

Tuition reimbursement

FreeU education

Diversity & inclusion

Job summary

Abbott in Lake Forest, IL is seeking a Senior Quality Auditor to lead the Infectious Disease BU audit program for RMDx entities and suppliers. You will perform internal and supplier audits, report findings, and coordinate with local site Quality teams. Role requires broad regulatory knowledge and regional travel.

The position emphasizes training, mentorship, and cross-site collaboration to strengthen Abbott's quality systems across the Diagnostics family.

Qualifications

• Bachelor’s degree in Science, Engineering, pharmaceuticals or equivalent.
• Minimum 8 years of experience with at least 3 years Quality work in medical device industry.
• Knowledge of QSR, ISO 13485, MDSAP, cGMP, MDR/IVDR regulations and relevant standards.

Responsibilities

• Develop and execute the ID BU audit program for RMDx entities and suppliers.
• Perform internal audits, prepare reports, and issue final audit findings.
• Collaborate with local site Quality teams and cross-site auditors.
• Train and mentor ID BU auditors and support corrective actions.

Skills

Quality Auditor

Auditing Skills

Regulatory knowledge

Travel readiness

Education

Bachelor’s Degree in Science/Engineering/pharmaceuticals or equivalent

Tools

MS Word

Excel

PowerPoint

Job description

Abbott in Lake Forest, IL is seeking a Senior Quality Auditor to lead the Infectious Disease BU audit program for RMDx entities and suppliers. You will perform internal and supplier audits, report findings, and coordinate with local site Quality teams. Role requires broad regulatory knowledge and regional travel.

The position emphasizes training, mentorship, and cross-site collaboration to strengthen Abbott's quality systems across the Diagnostics family.