Quality Systems Lead — Medical Devices & Compliance

Baxter International Inc.; Saint Paul (MN); Presencial; USD 88.000 - 121.000; Jornada completa

Descripción de la vacante

Baxter International Inc. is seeking a Quality Systems Specialist to strengthen and sustain our Quality Management System, ensuring compliance with global standards and supporting change control, investigations, audits, and product disposition across manufacturing and regulatory functions.

You will partner with cross-functional teams to drive continuous improvement, manage risk, and deliver high quality products to patients while traveling up to 10% for audits and site initiatives.

Formación

• Bachelor's degree required in a technical field in regulated manufacturing.
• Minimum 5+ years of quality systems experience in medical device, pharma, biotech, or combination products.
• Strong knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and risk management.

Responsabilidades

• Lead change controls with risk assessments, evidence, and implementation plans.
• Own CAPAs and nonconformance investigations with root-cause analysis and durable corrective actions.
• Collaborate across functions to resolve quality issues and ensure regulatory compliance.
• Review docs to support disposition decisions and ensure product quality.
• Support audits and ensure readiness across sites and systems.
• Monitor quality metrics, identify trends, and elevate issues as needed.
• Act as a SME for quality systems and drive continuous improvement.

Conocimientos

Quality systems

CAPA management

Root cause investigation

Regulatory knowledge

Technical writing

Cross-functional collaboration

Travel readiness

Educación

Bachelor's degree in Engineering, Quality, Life Sciences, Microbiology, Chemistry, or related technical field

Herramientas

TrackWise

Adobe approval workflows

ERP platforms

Descripción del empleo

Baxter International Inc. is seeking a Quality Systems Specialist to strengthen and sustain our Quality Management System, ensuring compliance with global standards and supporting change control, investigations, audits, and product disposition across manufacturing and regulatory functions.

You will partner with cross-functional teams to drive continuous improvement, manage risk, and deliver high quality products to patients while traveling up to 10% for audits and site initiatives.