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We are a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. We are seeking a talented QA /RA Engineer to join our quality and regulatory team, playing a dual role that ensures our products meet the highest quality standards while navigating complex global regulatory requirements.
SCOPE & RESPONSIBILITIES
Quality Assurance Manage ECOs: conduct risk assessments, update relevant DMR documents and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks. Manage DCOs in the PLM system : write and update QA procedures to ensure compliance with quality standards and regulatory requirements. Manage NCR and CAPA processes: lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions. Manage QA production activities: provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality. Ensure timely resolution of quality issues: promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations. Participate in internal and external audits, such as FDA inspections and notified body audits based on ISO 13485, EU MDR, and MDSAP requirements. Supplier Quality Management: manage supplier qualification and performance monitoring, including SCAR management, and support supplier audits.
Regulatory Affairs Prepare, coordinate, track, and follow up on submissions for medical devices across various international markets. Prepare and manage EU MDR technical documentation submissions. Oversee CER, PMS, and PMCF activities, including customer complaints, vigilance, and recall. Participate in regulatory inspections and audits. Prepare regulatory assessments for design changes. Develop labeling according to applicable regulatory requirements. Evaluate and communicate regulatory impact of ECOs and design changes across QA and RA domains.

Integration into departmental and divisional projects involving the development of systems and providing hardware testing solutions for new products.
Defining test processes and test setups for various hardware testing domains (voltage conversion/ RF/ audio/WIFI, .etc.)
Joining the ATE team and developing automated testing capabilities and additional applications in the LABVIEW environment.
Developing auxiliary tools and applications for divisional use across various development platforms.
Serving as a knowledge hub for test equipment
Leading automation development projects in collaboration wuth external outsourcing partners.

In this fully onsite role, the QA Engineer supports product developments and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.

The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.



Essential Duties and Responsibilities
QA focal point for R&D projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
Responsible for final approval of R&D and lab documentation- reviewing and approving technical and DHF documentation and lab work instructions/test method.
Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
Responsible for approval of product design changes and process changes (ECO)
Finding solutions for queries within responsibility limits
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in product development design reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
Attend program meetings as required as part of extended program teams
Responsible for approval of labelling

we are building an autonomous drone-delivery network for restaurants in suburban America. We are one of 4 companies that are FAA approved to fly over residential neighborhoods (together with Amazon, Google/Wing and Zipline) but are the only one exclusively focused on restaurants. Uber is an investor in Flytrex and we fly deliveries for Doordash as well. After thousands of successful commercial deliveries and multiple breakthrough FAA approvals, Flytrex is now expanding rapidly across the U.S., starting with Dallas Forth worth. Flytrex is revolutionizing the food delivery industry by making drone delivery a reality. We are looking for an experienced QA Engineer to join a fast-growing multidisciplinary team in our vibrant working environment in the center of Tel Aviv. This is a unique opportunity to work on the worlds leading drone delivery system and be a part of a revolution in the making. As a QA Engineer at Flytrex, you will be part of the team in charge of the quality of the companys products. Main Responsibilities:
* Performing comprehensive QA planning and coordination for multiple projects from the design stage until delivery.
* Collaborating with internal teams (Product, R&D, Field Engineering) to identify system requirements and plan a coherent TEST plan accordingly.
* Planning & developing automated tests for various components of the Flytrex system.
* Managing, analyzing, and handling support tickets that arise from the customers end.
* Creating detailed, comprehensive, and well-structured ATP, STP & STRs.
* Improving the company's products reliability levels.

We are looking for an experienced ATE Test Engineer to join our Quality and Operations team and help lead our products to a successful production launch. You will be part of a multi-geo team, collaborating with external suppliers and partners around the world.
In this role, you will develop ATE Test Programs and take full ownership of DFx definitions, evaluation, development, and debug of test methods working closely with design, component validation, systems, and other test engineering teams.
Responsibilities:
Develop Test programs (Wafers Sort and Final Test) for products
Define and co-design ATE hardware (Load Boards) and optimize High-Speed Testing methodologies (DDR and others).
Analyze and evaluate component specifications against real-world performance.
Analyze early customer returns with a focus on test hole closure activities.
Support yield optimization and debug initiatives.
Drive DFx support - including definitions, evaluation, development, and debug of test methods.
Collaborate cross-functionally with design, component validation, and systems engineering teams.

We are looking for an experienced and outstanding EMC Testing Engineer with the ability to understand complex systems and play a key role in the qualification of our revolutionary technologies.
What you'll do
Coordinate and perform hands-on EMC testing on full systems and components
Select, calibrate, and configure the right instrumentation (such as EMI Receiver, cables, antennas, LISN, coupling network, etc.)
Based on collected data and information, determine if specifications, regulations, customers expectations, and acceptance criteria are satisfied - According to automotive standards
Generate formal technical reports, and present conclusions to stakeholders
Conduct failure analysis investigations, diagnose failed components, and identify root causes
Recommend corrective actions (e.g. re-design Schematics, Components, Layout, etc.).

Required QA Engineer
As a QA Engineer, you will:
Lead technological projects, in system and quality aspects
Design detailed, comprehensive and well-structured test plans and test cases
Identify, document and manage bugs life cycle
Work closely with research, product, dev, DevOps and program managers to meet project timeline.

Eitan Medical is an international Medical Device company that develops and manufactures innovative medical equipment. Specifically, we develop infusion pumps and their related accessory products. Job Description: Eitan medical is looking for a highly motivated Software QA Engineer with strong manual testing capabilities, hands-on automation experience, and practical usage of AI tools for software quality and testing activities. As part of the Digital Health Department, you will be responsible for designing, planning, and executing test scenarios for complex medical software systems. The role combines manual testing, automation development, backend/API validation, and AI-assisted QA workflows to ensure high-quality and reliable products used in real-life patient care. You will work closely with R&D, Product, and System Engineering teams in a dynamic and fast-growing environment. Direct Manager: Digital Health SW QA Team Leader

Were looking for an experienced Automation Engineer to join our QA Automation team and help shape the future of quality at our company. In this role, youll play a critical part in developing innovative testing systems for our SaaS product-ensuring every release is fast, reliable, and built to scale.
Responsibilities
Lead the design, development, and maintenance of automated tests across UI, API, and integration layers.
Collaborate closely with developers and QA engineers to define robust test strategies and drive quality from the ground up.
Build and evolve scalable, maintainable test frameworks that empower fast and confident delivery.
Integrate automation into CI/CD pipelines, maintaining high coverage across services and components.
Participate in feature planning to align test efforts early and ensure full lifecycle coverage.
Leverage infrastructure-as-code and scripting to streamline and optimize testing environments.

Job Responsibilities:
Reports on the performance of all service providers, conducting daily, weekly, and monthly reviews to assess key metrics and identify opportunities for improvement, working under general supervision.
Delegates ownership of the warehousing operations in her/his scope, securing inbound goods receiving, storage, handling and picking/packing are executed efficiently with a focus on highest quality and patient safety, end-to-end optimization and in full compliance with processes defined and with quality, regulatory, sustainability, legal and trade compliance obligations.
Controls that execution of processes is done with focus on highest quality and patient safety, in full compliance with processes defined and with quality, regulatory, sustainability, legal and trade compliance obligations.
Ensures the quality assurance of master data and transactional data throughout the entirety of his/her operational activities, maintaining a stringent adherence to established protocols and standards to guarantee accuracy, consistency, and reliability across all created and updated records.
Supports daily inbound activities of the distribution center, including prioritizing tasks and resolving exceptions such as overdue Advanced Shipping Notice (ASN) checks, over- and under-deliveries, and inbound complaints.
Assists with daily outbound activities of the distribution center, prioritizing tasks and resolving exceptions such as overdue deliveries, overdue Proof of Delivery (POD) documents, and customer complaints.
Initiates process improvements for inbound and outbound activities based on root cause analysis of daily exceptions in operational processes, striving for continuous enhancement.
Conducts daily checks of interfaces between SAP, Transportation Management System (TMID), and Logistics Service Provider (LSP) systems to ensure data integrity and smooth information flow.
Ensures alignment between stock in SAP and Warehouse Management System (WMS) systems, conducting regular audits and reconciliations to maintain accuracy and safeguarding against potential disruptions to inventory management processes.
Coordinates rework activities for stocks, addressing quality issues, customer Value-Added Services (VAS) activities, and promotional VAS activities as requested by business units or marketing.
Prepares and maintains transportation plans for finished products within a long-term timeframe, validates transportation capacity, considering customer demand and promised delivery dates.
Calculates transportation capacity and develop transport plans on a long-term basis, adjusting schedules as necessary to optimize efficiency and meet strategic objectives.
Contributes to the implementation of new control systems and the improvement of planning procedures and methods as part of working groups, collaborating with cross-functional teams to drive efficiency and effectiveness.