Quality Systems Lead: Change Control, Audits & CAPAs

Baxter Healthcare; 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

Parental leave

Employee stock purchase plan

Job summary

At Baxter, a Quality Systems Specialist ensures the quality, safety, and reliability of medicines and medical devices. You will partner across manufacturing, engineering, regulatory affairs, and supplier quality to maintain the QMS, lead investigations, CAPAs, audits, and product disposition.

Based in our Quality organization, you will drive continuous improvement, support audits, and ensure compliance with global standards while enabling timely, high-quality product releases to patients and

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 (medical device/pharma/biotech).
• Experience managing CAPAs, nonconformance investigations, change controls, audit activities, and continuous improvement.
• Strong knowledge of FDA QSR (21 CFR Part 820)/QMSR, ISO 13485, and quality risk management.
• Ability to conduct investigations, analyze data, and communicate recommendations across functions.
• Strong technical writing, documentation review, organizational, and project prioritization skills.
• Ability to travel up to 10% to support audits and cross-site quality initiatives.

Responsibilities

• Lead quality review and approval for change controls with risk assessments and evidence.
• Own and coordinate nonconformance investigations and CAPAs with root-cause analysis.
• Collaborate with cross-functional teams to resolve quality issues and ensure regulatory compliance.
• Review manufacturing, inspection, and release docs to support product disposition decisions.
• Prepare documentation for audits and support audit outcomes.
• Monitor quality system performance, identify trends, and elevate risks.
• Serve as SME for document control and continuous improvement across sites.

Skills

Quality systems

Investigations

CAPA management

Cross-functional collaboration

Regulatory knowledge

Technical writing

Project prioritization

Communication

Education

Bachelor's degree in Engineering, Quality, Life Sciences, Microbiology, Chemistry or related field

Tools

TrackWise

Adobe approval workflows

ERP platforms

Job description

At Baxter, a Quality Systems Specialist ensures the quality, safety, and reliability of medicines and medical devices. You will partner across manufacturing, engineering, regulatory affairs, and supplier quality to maintain the QMS, lead investigations, CAPAs, audits, and product disposition.

Based in our Quality organization, you will drive continuous improvement, support audits, and ensure compliance with global standards while enabling timely, high-quality product releases to patients and