Quality Compliance Auditor II — Global Impact

Baxter; Round Lake Beach (IL); On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

401(k) plan

ESPP

Paid time off (20–35 days)

Job summary

Baxter is seeking a Quality Associate II who thrives in a collaborative environment and can guide audits and compliance initiatives. You will navigate complex regulatory data, train peers, and drive timely CAPA execution while maintaining safety and quality as top priorities.

The role involves leading audits, supporting inspections, and mentoring team members within the Quality organization, with a focus on continuous improvement and robust regulatory readiness.

Qualifications

• BS in business or science or equivalent degree.
• Minimum 3 years of Quality experience in a medical device/pharma or similarly regulated industry.
• ASQ CQA and/or other auditor accreditation strongly preferred.
• Extensive knowledge of GMP regulations and regulatory inspection processes.

Responsibilities

• Maintain Compliance Audit Quality Systems in accordance with applicable regulatory requirements.
• Lead internal and supplier audits; develop assessment strategy and verify evidence.
• Prepare management reports on audit findings, CAPA plans, and trend analyses.
• Mentor Quality Compliance Associates I and Technicians on audit methodology.
• Coordinate state licensing program and support regulatory inspections.

Skills

Communication skills

Analytical skills

Quality auditing

Regulatory knowledge

Team leadership

Education

BS in business or science

ASQ CQA certification (preferred)

Tools

TrackWise

MS Office

Job description

Baxter is seeking a Quality Associate II who thrives in a collaborative environment and can guide audits and compliance initiatives. You will navigate complex regulatory data, train peers, and drive timely CAPA execution while maintaining safety and quality as top priorities.

The role involves leading audits, supporting inspections, and mentoring team members within the Quality organization, with a focus on continuous improvement and robust regulatory readiness.