Overview
Quality Engineer Jobs in Chicago, IL at Sol-Millennium Medical Group
Title: Quality Engineer
Company: Sol-Millennium Medical Group
Location: Chicago, IL
SOL-MILLENNIUM Medical Group is an entrepreneurial global healthcare company dedicated to the research and development, manufacturing and distribution of high-quality medical devices that support best clinical practice while protecting healthcare workers and their patients from the risks associated with needlestick injury. The Company sells a broad range of medical products and services to hospitals, veterinary groups, medical supply companies, government health departments and scientific research facilities in 40 countries around the world.
Join our team at Sol-Millennium as an Associate Quality Engineer, where you’ll play a key role in supporting quality and compliance across our innovative medical device portfolio. This position offers an exciting opportunity to gain hands-on experience within a dynamic global team, contributing to the integrity of our products and the strength of our Quality Management System.
This role is ideal for someone eager to grow their expertise in regulatory compliance, technical documentation, and continuous improvement within the highly impactful medical device industry.
Key Responsibilities:
Support product evaluations to ensure conformance to specifications and regulatory expectations.
Participate in product release activities, ensuring documentation and quality records are complete and compliant.
Assist in the creation and maintenance of quality documentation, including Device Master Records (DMRs), technical files, and standard operating procedures.
Support post-market surveillance activities, including complaint investigations, adverse event documentation, and field actions.
Assist in responding to customer quality inquiries, including questionnaires, tenders, and audit requests.
Collaborate with cross-functional teams to support product quality improvements and supplier corrective actions.
Participate in internal audits and support external audits and inspections.
Maintain accurate records in accordance with good documentation practices (GDP).
Contribute to continuous improvement initiatives within the quality management system (QMS).
Required Qualifications:
Bachelor’s degree in scientific or engineering discipline (e.g., Biomedical Engineering, Mechanical Engineering, Life Sciences).
2+ Years of experience in Quality Assurance within the medical device industry or a regulated environment.
Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and EU MDR.
Proficiency with Microsoft Office and quality management systems.
Strong attention to detail and organizational skills.
Effective verbal and written communication abilities.
Ability to work collaboratively and independently in a team-oriented environment
About Sol-Millennium:
We are a global healthcare company dedicated to building a healthier tomorrow through the development, manufacture, and distribution of high-quality medical devices.
Visit our “About Us” page to learn more! https://naca.sol-m.com/about
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This job description is not intended to encompass all duties that may be required. Additional responsibilities in line with the original scope of work may arise as the business evolves.
Sol-Millennium is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment is decided on the basis of qualifications, merit, and business need.
