Principal Quality Engineer

Baxter seeks a Principal Quality Engineer to serve as a senior technical leader in the Quality organization. This role provides strategic quality direction for complex manufacturing, new product development, and continuous improvement while mentoring quality professionals and influencing cross-functional decisions.

Responsibilities

• Lead quality engineering for complex manufacturing, product development, and process improvement initiatives
• Serve as technical authority for risk assessments, design transfers, process controls, and compliance decisions
• Lead investigations of nonconforming product, complaints, CAPAs, and deviations using advanced root cause methodologies
• Establish quality plans, risk management files, inspection strategies, and process monitoring systems
• Represent Quality during regulatory inspections, customer audits, and support lead audit programs

Requirements

• Bachelor's degree in Engineering, Science, or related technical field
• 5-8 years of Quality Engineering experience in regulated medical device, biologics, or pharmaceutical industries
• Demonstrated technical leadership for complex quality and compliance initiatives
• Extensive knowledge of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, cGMP, and risk management
• Advanced experience with CAPA, nonconformance management, change control, supplier quality, and design controls
• Experience supporting injection molding manufacturing in regulated environments
• Strong analytical, statistical, and problem-solving skills with multi-functional leadership ability