Senior Quality Analyst – Depot Operations (Hybrid)

Regulatory Toolkit; Town of Skaneateles (NY); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Health benefits

ESPP

Paid time off 20-35 days

Job summary

Baxter is seeking a Quality Associate III based in Skaneateles Falls, NY. You will own and manage QMS processes for U.S. depot operations, and partner with Canadian depot ops to ensure consistency across UCAN. You will independently evaluate quality issues and drive practical, sustainable improvements.

You will lead investigations, CAPAs, and inspections, while collaborating with Service Operations and Global Quality to meet regulatory requirements and Baxter policies.

Qualifications

• Strong critical-thinking, analytical, and problem-solving skills to evaluate complex situations.
• Ability to own and manage quality-system processes and drive improvement.
• Sound judgment for risk-based quality decisions within authority.
• Knowledge of medical device quality-system requirements (FDA/ISO 13485).
• Experience with investigations, CAPA, change control, and audits.
• Ability to influence across functions and drive accountability.

Responsibilities

• Own and manage Quality Management System processes for U.S. depot operations.
• Serve as primary Quality SME for U.S. depot ops and align with UCAN.
• Provide oversight of depot service processes and drive standardization.
• Evaluate depot documentation, controls, validations, and adherence to procedures.
• Identify and resolve complex quality issues using risk-based thinking.
• Lead quality investigations, CAPAs, and change controls within authority.
• Plan risk-based depot assessments and drive corrective actions.
• Lead audit readiness and communicate risks and improvement plans.

Skills

Critical thinking

Analytical skills

Problem solving

Regulatory knowledge

Communication

Project management

Quality systems

Cross-functional influence

Organizational skills

Travel ability

Education

Bachelor's degree in engineering or science

ASQ/Lean/Six Sigma certification

Job description

Baxter is seeking a Quality Associate III based in Skaneateles Falls, NY. You will own and manage QMS processes for U.S. depot operations, and partner with Canadian depot ops to ensure consistency across UCAN. You will independently evaluate quality issues and drive practical, sustainable improvements.

You will lead investigations, CAPAs, and inspections, while collaborating with Service Operations and Global Quality to meet regulatory requirements and Baxter policies.