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Summary
As a Quality Associate III, you will own and manage assigned Quality Management System (QMS) processes supporting U.S. depot operations. Based in Skaneateles Falls, New York, this position serves as the primary Quality partner for U.S. depot operations and is accountable for process performance, compliance, risk identification, standardization, and continuous improvement. The role partners with Canadian depot operations to promote consistent execution of depot quality processes and alignment of Quality System requirements across UCAN. Independently evaluates complex quality and operational issues, applies critical thinking and risk-based decision-making, and drives practical, sustainable solutions. Partners with Service Operations and Global Service Quality to ensure depot processes comply with applicable regulatory requirements, Baxter policies, and approved procedures.
Essential Duties and Responsibilities
· Own and manage assigned Technical Services Quality Management System processes, including process requirements, controls, documentation, performance measures, governance, and continuous improvement.
· Serve as the primary Quality representative and subject matter expert for U.S. depot operations while partnering with Canadian depot operations to promote consistency and alignment across UCAN.
· Own assigned Quality Management System processes supporting U.S. depot operations. Provide oversight of depot service processes across U.S. depot locations and drive standardization, consistency, and alignment of Quality System requirements across UCAN depot operations.
· Evaluate depot service documentation, process controls, equipment and calibration controls, validations, material controls, and adherence to approved service procedures.
· Independently identify, analyze, and resolve complex quality and compliance issues using critical thinking, structured problem-solving, root-cause analysis, and risk-based decision-making.
· Lead or provide Quality approval for investigations, nonconformances, CAPAs, effectiveness checks, change controls, risk assessments, validations, and other quality records within delegated authority.
· Plan and conduct risk-based depot assessments; identify systemic gaps, establish improvement priorities, monitor effectiveness, and drive sustainable corrective actions across depot operations.
· Lead audit and inspection readiness activities, monitor quality metrics and trends, communicate risks and improvement plans through Management Review and leadership forums, and drive continuous improvement initiatives that support consistency and standardization across UCAN depot operations.
Qualifications
· Strong critical-thinking, analytical, and problem-solving skills with the ability to independently evaluate complex or ambiguous situations.
· Demonstrated ability to own and manage quality-system processes and drive measurable, sustainable improvement.
· Sound judgment and demonstrated ability to make risk-based quality decisions within delegated authority.
· Strong knowledge of medical device quality-system requirements, including applicable FDA…