Senior Quality Auditor – ID Compliance & Audits

Regulatory Jobs; Lake Forest (IL); Sur place; USD 87 000 - 173 000; Plein temps

Avantages offerts par ce poste

Free medical coverage (HIP PPO) in the

Great retirement savings plan

Tuition reimbursement

Freedom to Save education benefit

Diversity and recognition programs

Résumé du poste

Abbott in Lake Forest, IL, is seeking a Senior Quality Auditor to lead the Infectious Disease BU audit program and perform internal and supplier audits across regions. The role requires deep regulatory knowledge, robust auditing experience, and collaboration with global quality teams.

You will develop audit standards, train auditors, and drive corrective actions to ensure cGMP, ISO 13485, and MDR/IVDR compliance while supporting cross-site audits and travel up to 60% as needed.

Qualifications

• Bachelor’s degree in science, engineering, pharmaceuticals or equivalent.
• 8+ years total experience with at least 3 years in quality in medical device industry, including Quality Systems Auditor.
• In-depth knowledge of QSR, ISO 13485, MDSAP, cGMP, MDR/IVDR and related standards.

Responsabilités

• Develop and execute Infectious Disease BU audit program for Abbott RMDx.
• Perform internal audits of sites and suppliers; support cross-site audits.
• Lead audit schedule, prepare, conduct, and issue final audit reports.
• Train and mentor ID BU auditors; support corrective actions and root-cause analysis.
• Collaborate with local site Quality teams to maintain compliance.

Connaissances

Quality Auditor

Regulatory compliance

Auditing standards

Communication skills

Formation

Bachelor’s Degree in Science/Engineering/Pharma

Outils

MS Word

MS Excel

PowerPoint

Description du poste

Abbott in Lake Forest, IL, is seeking a Senior Quality Auditor to lead the Infectious Disease BU audit program and perform internal and supplier audits across regions. The role requires deep regulatory knowledge, robust auditing experience, and collaboration with global quality teams.

You will develop audit standards, train auditors, and drive corrective actions to ensure cGMP, ISO 13485, and MDR/IVDR compliance while supporting cross-site audits and travel up to 60% as needed.