Senior Quality Auditor – Medical Devices & Diagnostics

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

Job summary

Abbott in Lake Forest, IL is seeking a Senior Quality Auditor to design and execute the Infectious Disease BU audit program for Abbott Diagnostics. You will lead internal audits, develop audit standards, and collaborate across sites to ensure regulatory compliance and effective quality systems.

The role requires deep QA expertise in medical devices, knowledge of QSR/ISO13485, and willingness to travel up to 60% to support sites and suppliers. Abbott offers strong growth opportunities.

Qualifications

• Minimum 8 years of experience with at least 3 years QA in medical device industry.
• Experience as a Quality Systems Auditor.
• Strong knowledge of QSR, ISO13485, MDSAP, cGMP, MDR/IVDR.

Responsibilities

• Execute ID internal audit schedule and audits.
• Develop and maintain ID BU audit standards.
• Lead cross-site audits and training programs.
• Support corrective actions and training.
• Collaborate with local Quality teams.
• Ensure audits comply with ISO, FDA, and regulatory standards.

Skills

Quality auditing

Regulatory knowledge

Audit leadership

Cross-functional collaboration

Documentation

Training

Education

Bachelor’s Degree in Science/Engineering/Pharmaceuticals

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Abbott in Lake Forest, IL is seeking a Senior Quality Auditor to design and execute the Infectious Disease BU audit program for Abbott Diagnostics. You will lead internal audits, develop audit standards, and collaborate across sites to ensure regulatory compliance and effective quality systems.

The role requires deep QA expertise in medical devices, knowledge of QSR/ISO13485, and willingness to travel up to 60% to support sites and suppliers. Abbott offers strong growth opportunities.