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 digitalhealth company specializing in the development of hybrid drugs – a product thatincludes a traditional pharmacological component and a digitaltherapeutic app. Remepy’sdigital therapeutics applications are developed as Software as a Medical Device(SaMD), in accordance with applicable medical device regulations of the US Foodand Drug Administration (FDA) and the International Organization of Standards(ISO). The company is headquartered in the US with R&D operations in RamatGan, Israel. As the legal manufacturer, Remepy is responsible for managementoversight, 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, revisioncontrol, 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 designchanges.
- Maintain design traceability matrices and support identification,resolution, and documentation of gaps between requirements, risks, softwareimplementation, testing, and released configurations.
- Support CAPA activities, including issue intake, investigation, rootcause analysis, corrective and preventive action planning, implementationtracking, effectiveness checks, and timely closure.
- Administer complaint handling records, coordinate technicalinvestigations and product impact assessments, trend complaints, and escalatepotential reportable events to Quality and Regulatory Affairs fordetermination.
- Support software change control, release documentation, nonconformanceand deviation management, and assessment of impacts on design documentation,risk controls, and verification or validation.
- Collaborate with software, product, and clinical teams to ensure riskmanagement records, usability engineering evidence, and cybersecurity-relateddesign 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; trackfindings and associated remediation actions.
- Monitor quality metrics and trends related to design documentation,CAPA, complaints, and process performance; recommend practical improvements todocumentation and workflows.
- Support implementation and maintenance of QMS procedures and templates,provide training on applicable quality processes, support training managementactivities, and promote consistent documentation practices across teams.
- Support implementation, configuration, validation, andongoing optimization of an electronic Quality Management System (eQMS),including migration of existing quality records, development of electronicworkflows, 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 inmedical devices, including software devices; direct SaMD or digital healthexperience 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.
- Demonstratedexperience maintaining DHF and/or MDF documentation, design traceability,design change records, and software lifecycle deliverables.
- Hands-on experiencesupporting CAPA investigations, complaint handling, nonconformance management,and audit preparation.
- Familiarity withsoftware development lifecycles, agile teams, electronic QMS/documentmanagement systems, and cross-functional technical reviews.
- Strong attention todetail, technical writing, problem-solving, communication, and ability tomanage multiple priorities in a collaborative, fast-paced start-up environment.