Job Summary

• This role partners with cross-functional teams across R&D, Quality, Operations, and Regulatory to execute high-impact projects, with a strong emphasis on CAPA (Corrective and Preventive Action) excellence.
• The role will lead process improvements, drive operational efficiency, and ensure compliance with FDA regulations, ISO standards, and internal quality procedures.
• We are looking for a dynamic Staff Engineer to drive strategic projects, with CAPA process transformation, with a focus on root cause investigation and action planning.

Matching Summary

Salary

Base: $124,700.00 - $205,800.00 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Key Requirements

• Bachelor’s degree in Engineering or Science
• minimum of 5 years of engineering experience
• medical device industry experience
• expertise in CAPA and Quality Systems preferred
• Experience conducting effective root cause investigation
• Experience with non-conformances, corrective and preventive actions
• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485

Work Rights