Senior Quality Associate – Depot Operations

Zvh; Skaneateles Falls (NY); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health benefits

ESPP

401(k)

Paid time off

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, ensuring compliance and driving continuous improvement across UCAN.

This role partners with Canadian depot operations to promote consistency and alignment with Quality System requirements. Responsibilities include leading audits and risk assessments, resolving complex quality issues, and providing quality approval for investigations, CAPAs, and change

Qualifications

• Bachelor's degree in engineering, science, or related technical discipline.
• 5+ years experience in Quality or regulated environment.
• Medical device industry experience strongly preferred.
• Experience leading quality-system processes and cross-functional initiatives.
• Knowledge of FDA, ISO 13485, GMP, and data integrity.

Responsibilities

• Own and manage QMS processes for U.S. depot operations.
• Primary Quality representative for U.S. depot ops; align with Canada (UCAN).
• Oversee depot service processes; drive standardization across UCAN.
• Evaluate depot docs, controls, validations, material controls, and procedures.
• Identify and resolve complex quality issues using risk-based thinking.
• Lead investigations, CAPAs, change controls within delegated authority.

Skills

Critical thinking

Quality ownership

Risk-based decisions

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering/science/related technical discipline

5+ years in Quality or regulated environment

Medical device industry experience

ASQ certification (preferred)

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, ensuring compliance and driving continuous improvement across UCAN.

This role partners with Canadian depot operations to promote consistency and alignment with Quality System requirements. Responsibilities include leading audits and risk assessments, resolving complex quality issues, and providing quality approval for investigations, CAPAs, and change