Senior Quality Engineer, New Product Introduction (24 Months fixed term)

Responsibilities

• Lead risk assessments and define quality controls for materials, processes, and product release
• Develop and validate inspection methods including Gage R&R and measurement system analysis
• Execute supplier qualification activities through PPAP and verify site implementation of controls
• Develop and execute process validation strategies with statistical justification and worst-case testing
• Monitor post-launch performance through quality metrics analysis and CAPA investigations

Requirements

• Bachelor's degree in Engineering, Quality, Manufacturing, or related technical field
• Minimum 4 years quality or manufacturing engineering experience in regulated industry
• Process validation experience aligned with FDA Quality System Regulation and ISO standards
• Fluent in English and Spanish, written and spoken
• PPAP, risk management methodologies, and supplier quality activity experience
• Statistical tools proficiency including hypothesis testing, capability analysis, and DOE

Compensation: $69,500 - $110,900 USD annual