Senior Quality Specialist — Depot Operations (US/UCAN)

Baxter International; Town of Skaneateles (NY); Hybrid; USD 96,000 - 132,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with company match

Paid time off

Job summary

Baxter International Inc. in Skaneateles Falls, NY, seeks a Quality Associate III to own and manage QMS processes for U.S. depot operations.

You will partner with Canadian depot operations to standardize Quality System requirements across UCAN, applying risk-based decision making and driving sustainable improvements. You will lead investigations, CAPAs, and change controls, ensuring compliance with FDA, ISO 13485, and GMP, while coordinating with Service Operations and Global Quality to maintain

Qualifications

• Bachelor’s degree in engineering, science, or a related technical discipline.
• 5+ years in Quality, Service, Manufacturing, Engineering, or a regulated environment.
• Medical device industry experience preferred.
• Experience managing quality-system processes and leading cross-functional quality or process-improvement initiatives.
• Audits, assessments, investigations, CAPA activities, and quality-system improvements in a regulated environment.
• Internal Auditor, ASQ, Lean, Six Sigma, or comparable quality certification preferred.

Responsibilities

• Own and manage Quality Management System processes for U.S. depot operations.
• Provide oversight of depot service processes and drive standardization across UCAN.
• Evaluate depot service docs, controls, calibrations, validations, and procedures.
• Identify, analyze, and resolve complex quality and compliance issues with risk thinking.
• Lead investigations, nonconformances, CAPAs, and change controls within delegated authority.
• Plan risk-based depot assessments; target systemic gaps and drive corrective actions.
• Lead audit readiness activities and monitor quality trends and metrics.
• Communicate risks and improvement plans in leadership forums.

Skills

Critical thinking

Quality management

Regulatory knowledge

Investigations

CAPA

Root cause analysis

Communication

Audit readiness

Education

Bachelor’s degree in engineering or science

ASQ / Lean Six Sigma certification preferred

Job description

Baxter International Inc. in Skaneateles Falls, NY, seeks a Quality Associate III to own and manage QMS processes for U.S. depot operations.

You will partner with Canadian depot operations to standardize Quality System requirements across UCAN, applying risk-based decision making and driving sustainable improvements. You will lead investigations, CAPAs, and change controls, ensuring compliance with FDA, ISO 13485, and GMP, while coordinating with Service Operations and Global Quality to maintain