Quality Engineer II
Listed on 2026-07-01
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Engineering
Quality Engineering, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Quality Engineer II - Remote
Seeking a Quality Engineer with experience supporting product quality throughout the product lifecycle in a regulated manufacturing environment. This role serves as a key liaison between Engineering, Manufacturing, and Suppliers, supporting design transfer, process validation, quality systems, and continuous improvement initiatives. Enterprise-level support with heavy focus on design control activity.
Key Qualifications:
- Bachelor's degree in Engineering or related field
- 5+ years of experience in a regulated medical device manufacturing environment
- Strong experience with process validation and quality engineering principles
- Knowledge of FDA regulations / ISO, design controls, and manufacturing quality systems
- Experience with root cause analysis, CAPA, statistical analysis, and process improvement methodologies
- Six Sigma and/or CQE certification preferred
- Strong problem-solving, communication, and cross-functional collaboration skills
This is an excellent opportunity for a hands-on quality professional who enjoys driving quality improvements, supporting new product introductions, and partnering across engineering and operations teams. Remote-based in the US; preference in Chicago or Wisconsin to be able to visit site locations. Ability to travel to the Mexico site as well. Bilingual English/Spanish a huge plus. Compensation 90-110k plus 10% bonus
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