Quality Engineer
Location
Chicago, IL
Level
Mid-Level
Department
Semiconductors
Type
Salary
$80,000 - $105,000
Job Description
Posted on:
2025-11-19
Responsibilities
- Develop project quality plans for new products and modifications.
- Facilitate measurement plans and lead product qualification.
- Ensure compliance with ISO13485 and FDA regulations.
- Manage customer acceptance documentation and corrective actions.
- Review and approve suppliers’ product documentation.
- Lead problem-solving efforts for product-related quality issues.
- Support systemic improvements to reduce quality notifications.
Job Requirements
- Bachelor's Degree in Engineering or related field.
- 3+ years of Quality Engineering experience in manufacturing.
- 2+ years of experience in medical device manufacturing.
- Experience interfacing with the FDA.
- Knowledge of statistics with Minitab or similar software.
- Ability to work with cross-functional teams.
- Willingness to travel domestically and internationally (5%-10%).
