Quality Systems Specialist

Retham Technologies, Inc. is a clinical diagnostic start-up company developing an IVD assay for a blood clotting disorder, heparin-induced thrombocytopenia. The company is conducting clinical trials of the IVD with plans to file for regulatory clearance followed by market launch. Job Title: Quality Systems Specialist Status: Full-Time or Part-Time role (20-40 hrs/week) Job Summary: The Quality System Specialist leads the development, maintenance, and continuous improvement of the company’s Quality Management System (QMS) in compliance with ISO 13485 and FDA QMSR standards. This role ensures that all quality processes, records, and documentation meet applicable regulatory and customer requirements. The Specialist will collaborate with cross‑functional teams to promote a strong quality culture, maintain compliance, and drive system effectiveness. ESSENTIAL DUTIES Implement, maintain, and continuously improve the Quality Management System to comply with ISO 13485 and FDA QMSR standards Provide training to employees on ISO and regulatory requirements, documentation procedures, and quality system changes Administer the document control process, including approvals, revisions, and obsolescence Ensure controlled distribution, revision, and accessibility of procedures, forms, and work instructions Plan, schedule, and conduct internal quality audits Lead preparation for customer and supplier audits, external certification, regulatory and surveillance audits Track and verify completion of QMS corrective actions from audits, nonconformances, or management reviews Facilitate and document Corrective and Preventive Actions (CAPA) for QMS findings Ensure root cause analysis and effective verification of implemented solutions Support risk management activities related to quality system compliance Comply with legal and regulatory requirements applicable to our business MANDATORY QUALIFICATIONS Bachelor’s degree in Quality, Engineering, or a relevant scientific discipline Working knowledge of ISO 13485 requirements Experience working in a Quality Management setting for FDA regulated products Proficient using Microsoft Office and standard office software solutions PREFERRED QUALIFICATIONS Experience with electronic QMS systems Knowledge of FDA regulations related to medical device manufacturing (QMSR). WORK LOCATION: In office with flexibility #J-18808-Ljbffr