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 innovative team at Sol-Millennium, a forward-thinking medical device company, as our Senior Quality Engineer. In this crucial role, you will be instrumental in maintaining our commitment to excellence by ensuring continuous compliance with Quality Management System standards and Regulatory requirements, pivotal in the medical device industry. Product lines include but are not limited to medication delivery, vascular access, blood collection, diabetes management, wound care and infection prevention.

REQUIRED QUALIFICATIONS:

• Bachelor or above in engineering or scientific discipline such as Biomedical Engineering.
• A minimum of 7 years of experience with quality assurance in the medical devices industry, specifically working with FDA regulated devices.
• Strong analytical skills and attention to detail.
• Excellent verbal and written communication skills.
• Ability to work independently in a dynamic and fast-paced environment.
• Working knowledge of ISO13485/EU MDR/FDA 21 CFR 820

• Develop and execute test plans and product evaluation protocols on new products to ensure compliance with appropriate performance and regulatory standards.
• Build product dossiers, such as technical files and Device Master Records (DMR) and ensure compliance with applicable regulations (MDSAP, FDA, Health Canada, EU MDR, Anvisa etc)
• Collaborate with Regulatory Affairs to prepare, submit and obtain clearance for 510(k)’s as well appropriately document Letters to File (LTF’s).
• Oversee the post market surveillance (complaint handling, adverse event reporting, field corrective actions, etc) process to ensure compliance with applicable regulations as well as customer satisfaction.
• Provide quality approvals of plans, procedures, and reports for verification and validation activities
• Work with Business Unit leaders and the sales team to address customer requests such as tenders, questionnaires and agreements.
• Ensure continuous development by driving product improvements and supplier corrective actions with relevant stakeholders.
• Own the “end to end” Quality/Regulatory results for assigned product categories, including but not limited to specification development, supplier selection, customer feedback and post market surveillance reports.