Quality Systems Lead: Change Control & CAPA Expert

Baxter International Inc.; Saint Paul (MN); On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Baxter International Inc. is seeking a Quality Systems Specialist to strengthen and sustain the Quality Management System, ensuring regulatory compliance and product quality across sites.

You will guide change controls, investigations, audits, and product release activities while collaborating with manufacturing, regulatory affairs, and supplier quality teams. Join a role that drives continuous improvement, supports business continuity, and strengthens Baxter’s commitment to safe, high-quality

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, Microbiology, Chemistry, or related field.
• 5+ years of experience supporting quality systems in regulated manufacturing environments.
• Experience managing CAPAs, nonconformance investigations, change controls, audits and improvements.
• Strong knowledge of FDA QSR (21 CFR Part 820)/ISO 13485 and quality risk management.
• Excellent technical writing, documentation review and cross-functional communication.
• Willingness to travel up to 10% as needed.

Responsibilities

• Lead quality review and approval for change control records with risk assessments and plans.
• Own CAPA investigations and ensure timely root-cause analysis and corrective actions.
• Collaborate with cross-functional teams to resolve quality issues and improve processes.
• Review manufacturing, inspection, and release docs to support product disposition.
• Prepare documentation for audits and contribute to audit outcomes.
• Monitor quality system metrics, identify trends and escalate risks.
• Serve as a quality systems SME supporting document control and continuous improvement.

Skills

Quality systems

CAPA investigations

Change controls

Audits

Regulatory compliance

Risk management

Documentation

Education

Bachelor’s degree in Engineering/Quality/Life Sciences

Tools

TrackWise

Adobe approvals workflows

ERP platforms

Job description

Baxter International Inc. is seeking a Quality Systems Specialist to strengthen and sustain the Quality Management System, ensuring regulatory compliance and product quality across sites.

You will guide change controls, investigations, audits, and product release activities while collaborating with manufacturing, regulatory affairs, and supplier quality teams. Join a role that drives continuous improvement, supports business continuity, and strengthens Baxter’s commitment to safe, high-quality