Quality Lead QMS & Depot Operations (US)

Baxter; Skaneateles Falls (NY); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Baxter in Skaneateles Falls, NY, seeks a Quality Associate III to own and manage key QMS processes supporting U.S. depot operations. You will serve as the primary Quality partner for U.S.

depots, driving process performance, compliance, and continuous improvement. This role requires evaluating complex quality issues, applying risk-based decision making, and aligning Quality System requirements across UCAN. Collaboration with Service Operations and Global Quality is essential as you lead

Qualifications

• Bachelor's degree in engineering, science, or related technical field.
• Minimum five years in Quality, Service, Manufacturing, or regulated environment.
• Experience with medical device quality systems and regulatory requirements.

Responsibilities

• Own and manage assigned Quality Management System processes for U.S. depot operations.
• Serve as the primary Quality representative for U.S. depot operations and align with UCAN.
• Oversee depot service processes and standardize Quality System requirements.
• Evaluate depot documentation, controls, validations, and material controls.
• Identify, analyze, and resolve complex quality issues using risk-based methods.
• Lead investigations, nonconformances, CAPAs, and change controls.
• Plan risk-based depot assessments and drive corrective actions.
• Lead audit readiness and communicate risks through reviews.

Skills

Critical thinking

Quality management

Risk-based decision making

Cross-functional collaboration

Technical writing

Communication

Project management

Multisite coordination

Education

Bachelor's degree in engineering/science

5+ years in quality/regulatory

Medical device industry experience

Tools

QMS familiarity

CAPA tracking

Audit processes

Job description

Baxter in Skaneateles Falls, NY, seeks a Quality Associate III to own and manage key QMS processes supporting U.S. depot operations. You will serve as the primary Quality partner for U.S.

depots, driving process performance, compliance, and continuous improvement. This role requires evaluating complex quality issues, applying risk-based decision making, and aligning Quality System requirements across UCAN. Collaboration with Service Operations and Global Quality is essential as you lead