Quality Systems Specialist

Baxter seeks a Quality Systems Specialist to support quality management, regulatory compliance, and operational excellence in a medical device manufacturing environment. The role involves overseeing change controls, investigations, audits, and product disposition across multiple cross-functional teams to ensure safe, compliant products.

Responsibilities

• Lead quality review and approval of change control records with risk assessments and implementation plans
• Own nonconformance investigations and corrective actions, driving root cause analysis and sustainable solutions
• Partner across functions to resolve quality issues and maintain regulatory compliance
• Review manufacturing and release documentation to support product disposition decisions
• Support internal, customer, and regulatory audits with documentation and evidence preparation

Requirements

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical field
• 5+ years supporting quality systems in medical device, pharmaceutical, or biotech industries
• Experience managing CAPAs, investigations, change controls, and audit activities
• Strong knowledge of FDA 21 CFR Part 820/QMSR and ISO 13485 standards
• Demonstrated data analysis, problem-solving, and technical writing skills
• Ability to travel up to 10% for audits and multi-site quality initiatives

Compensation: $88,000 - $121,000 base annually