Principal Quality Engineer

Abbott seeks a Principal Quality Engineer to lead complaint investigations and quality system improvements across FDA/ISO regulated medical device operations. The role involves cross-functional liaison work, root cause analysis, and setting global quality standards while translating business strategy into operational objectives.

Responsibilities

• Serve as technical lead and cross-functional liaison for complaint investigations involving R&D, Operations, and Quality
• Develop test methods and conduct root cause analysis to identify sources of product complaints
• Implement quality system improvements and establish global standards for specifications and critical quality attributes
• Ensure investigation results are communicated to relevant subject matter experts and regulatory compliance is maintained
• Translate business strategy into quality objectives and adjust processes to anticipate future regulatory and operational needs

Requirements

• Bachelor's degree in mathematics, science, or engineering discipline
• Minimum 5 years of quality experience in FDA/ISO regulated environment
• Technical depth in complaint analysis and investigation processes
• Strong data analysis and interpretation skills
• Project management capabilities with ability to multitask and prioritize
• Experience leading teams and developing team members (preferred)