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

Stryker · Arroyo

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QualityFull-time$70k–$111kCompany career page

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What they're looking for

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

What you'll be doing

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

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