Quality Engineer

The Quality Engineer position supports Remepy’s quality management activities for digital therapeutics and Software as a Medical Device (SaMD) products, with primary responsibility for maintaining complete and inspection-ready Medical Device Files (MDF) and technical documentation, coordinating design control deliverables, supporting internal and external audit readiness, and executing CAPA and complaint handling processes. This hands-on role works closely with Product, Software Engineering, Clinical, Regulatory Affairs, and Quality to ensure objective evidence of product conformity is accurate, traceable, controlled, and available throughout the product lifecycle. Company Overview Remepy is a digital health company specializing in the development of hybrid drugs – a product that includes a traditional pharmacological component and a digital therapeutic app. Remepy’s digital therapeutics applications are developed as Software as a Medical Device(SaMD), in accordance with applicable medical device regulations of the US Food and Drug Administration (FDA) and the International Organization of Standards(ISO). The company is headquartered in the US with R&D operations in Ramat Gan, Israel. As the legal manufacturer, Remepy is responsible for management oversight, regulatory affairs, quality system compliance, document control, design and development, procurement, marketing and sales, complaint handling, manufacturing, and distribution or deployment of its products. Major Duties & Responsibilities Maintain and organize Medical Device Files (MDF) and TechnicalDocumentation for SaMD products, ensuring document completeness, revision control, traceability, timely updates, and audit readiness. Coordinate and review design control deliverables, including design anddevelopment plans, user needs, design inputs and outputs, design reviews, verification and validation evidence, design transfer records, and design changes. Maintain design traceability matrices and support identification, resolution, and documentation of gaps between requirements, risks, software implementation, testing, and released configurations. Support CAPA activities, including issue intake, investigation, root cause analysis, corrective and preventive action planning, implementation tracking, effectiveness checks, and timely closure. Administer complaint handling records, coordinate technical investigations and product impact assessments, trend complaints, and escalate potential reportable events to Quality and Regulatory Affairs for determination. Support software change control, release documentation, nonconformance and deviation management, and assessment of impacts on design documentation, risk controls, and verification or validation. Collaborate with software, product, and clinical teams to ensure risk management records, usability engineering evidence, and cybersecurity-related design documentation are appropriately linked to the DHF/MDF and TechnicalDocumentation. Prepare quality records and evidence packages for internal audits, external partner audits, regulatory inspections, and submissions; track findings and associated remediation actions. Monitor quality metrics and trends related to design documentation,CAPA, complaints, and process performance; recommend practical improvements to documentation and workflows. Support implementation and maintenance of QMS procedures and templates, provide training on applicable quality processes, support training management activities, and promote consistent documentation practices across teams. Support implementation, configuration, validation, and ongoing optimization of an electronic Quality Management System (eQMS),including migration of existing quality records, development of electronic workflows, and ensuring compliance with applicable regulatory requirements, including FDA 21 CFR Part 11 and ISO 13485. Preferred Qualifications Bachelor’s degree in engineering, computer science, life sciences, or arelated technical discipline. 3–5+ years of quality engineering or design assurance experience in medical devices, including software devices; direct SaMD or digital health experience strongly preferred. Working knowledge of ISO 13485, FDA 21 CFR Part 820 (QMSR), IEC 62304,ISO 14971, and design control principles; familiarity with 21 CFR Part 11, IEC62366-1, IEC 81001-5-1, and AAMI TIR57 is beneficial. Demonstrated experience maintaining DHF and/or MDF documentation, design traceability, design change records, and software lifecycle deliverables. Hands-on experience supporting CAPA investigations, complaint handling, nonconformance management, and audit preparation. Familiarity with software development lifecycles, agile teams, electronic QMS/document management systems, and cross-functional technical reviews. Strong attention to detail, technical writing, problem-solving, communication, and ability to manage multiple priorities in a collaborative, fast-paced start-up environment. If you’re ready to bring your passion to help create the future of medicine, we’d love to have you on our team!