Chicago, Illinois
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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What We Do
We are one of the world's largest manufacturers of needles and syringes. We are vertically integrated with locations across the globe. Our innovative technology helps reduce unnecessary injuries, saves on medication and enhances both clinician and patient experience. Our international sales team is dedicated to delivering knowledge and outstanding customer service. Our goal is to partner with those in healthcare, focusing on a healthier tomorrow.
Originally a leading producer of plastic moulds for the global medical industry - we were the first syringe mould producer in China and now supply over 60% of China’s syringe mould needs, as well exporting globally.
This background sets the stage for our current focus in developing high quality and affordable safety medical devices that support best clinical practice – whilst also protecting healthcare workers (and their patients) from the risks associated with needlestick injury and accidental blood exposure.
We currently manufacture a range of safety syringes, needles and blood collection devices under the Sol-Care and Sol-Guard brands. We also produce syringes and needles for the veterinary industry under the Sol-Vet line of products, as well as an extensive range of standard (non-safety) needles and syringes.
We have a rich pipeline of new product innovation, and ambitious plans to grow our brands and our business.
Close collaboration with frontline healthcare professionals is critical to the way we work – by sharing knowledge and ideas together we continuously improve our offer and work toward our goal of ‘Building a Heathier Tomorrow’.
Sol Millennium has global presence with sales and marketing offices in Brazil, Poland and USA and a European R&D Centre, based in Switzerland
