Quality Engineer II - Quality Management System

About the role

Baxter is looking for a Quality Excellence Engineer to help drive the effectiveness and continuous improvement of its Quality Management System (QMS). The role combines quality systems expertise, risk-based decision-making and cross-functional leadership to identify systemic gaps, implement sustainable solutions and strengthen compliance in a highly regulated medical device environment. You will influence key quality initiatives and work with stakeholders across Quality, Manufacturing, Engineering, Validation and Regulatory Affairs.

Key responsibilities

• Evaluate QMS processes through assessments, audits, quality metrics and trend analysis to identify systemic risks and improvement opportunities.
• Lead quality remediation plans and quality excellence initiatives, setting clear objectives, timelines, governance and measurable outcomes.
• Partner with cross-functional teams to implement corrective actions and strengthen compliance while protecting product quality and patient safety.
• Apply risk management principles to identify, assess, mitigate and monitor quality risks affecting regulatory compliance, operational continuity or product quality.
• Analyze trends, recurring quality issues, CAPAs, audits and nonconformances to find systemic improvement opportunities.
• Drive inspection and audit readiness and foster a culture of accountability and continuous improvement.

Required profile

• Bachelor's degree in Industrial Engineering, Manufacturing Engineering or a related technical discipline.
• 3+ years of experience in a regulated industry, preferably medical devices, in Quality Systems, Quality Engineering, Compliance or related quality functions.
• Experience leading or supporting Quality Plans, remediation initiatives, complex CAPAs, quality system improvements or gap assessments.
• Proven ability to collaborate across functions, influence stakeholders and coordinate initiatives without direct authority.
• Advanced written and verbal English.

Required skills

• Strong understanding of Quality Management Systems, GMP, ISO 13485, quality risk management and regulatory compliance.
• Preferred: training or certification in ISO 13485, ISO 14971, quality systems auditing or project management.
• Preferred: experience supporting regulatory inspections and audit readiness; knowledge of Lean, Six Sigma or other continuous improvement methods; Power BI proficiency.