Senior Quality Systems Specialist

Senior Quality Systems Specialist Retham Technologies, Inc. Wauwatosa, WI 53226 Join an innovative clinical diagnostics startup bringing a breakthrough diagnostic to hospital laboratories. Retham Technologies is developing a first-of-its-kind in vitro diagnostic (IVD) assay for heparin-induced thrombocytopenia (HIT), a life-threatening blood clotting disorder. Backed by more than $6 million in NIH funding, our team is preparing for FDA submission and commercialization. We are seeking an experienced Senior Quality Systems Specialist to help build a world-class Quality Management System while working directly with company leadership in a collaborative startup environment. Position Senior Quality Systems Specialist Full-Time or Part-Time (20–40 hours/week) Location: Wauwatosa, WI (on-site preferred, open to hybrid) Basic Requirements Authorized to work in the United States without current or future visa sponsorship Able to work primarily on-site in Wauwatosa, WI (open to hybrid) Prior quality experience in an FDA-regulated medical device, IVD, biotechnology, or life sciences company Position Summary Lead implementation, maintenance, and continuous improvement of Retham's Quality Management System in compliance with ISO 13485 and FDA QMSR. Partner closely with leadership, R&D, operations, and regulatory to support FDA clearance and commercialization. Key Responsibilities Implement and continuously improve the ISO 13485-compliant electronic QMS Administer document control Plan and conduct internal quality audits Prepare for customer, supplier, certification, and FDA audits Lead CAPA activities and root cause investigations Support supplier qualification and quality agreements Support risk management and management review Train employees on quality system requirements Success in Your First Year Complete implementation of the company's core QMS Support FDA submission activities Strengthen supplier quality processes Foster a strong quality culture across the organization Required Qualifications Bachelor's degree in Quality, Engineering, Biology, Chemistry, or related scientific discipline 3+ years of Quality Systems experience in an FDA-regulated medical device or IVD company Working knowledge of ISO 13485 and FDA QMSR/QSR Experience with document control, CAPA, internal audits, supplier quality, and/or risk management Strong technical writing and Microsoft Office skills Preferred Qualifications Experience in an IVD or diagnostics company Experience supporting FDA 510(k) submissions Experience with electronic QMS software ASQ CQA certification Startup or small-company experience Why Join Retham Direct interaction with executive leadership Opportunity to build a quality system from the ground up Meaningful ownership and visibility Equity participation opportunity Flexible work schedule Competitive salary Equal Opportunity Retham Technologies is an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to any protected status. Applicants must be authorized to work in the United States without the need for visa sponsorship now or in the future. #J-18808-Ljbffr Retham Technologies