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We are seeking a highly skilled QA and Design Control Manager with proven experience in the medical devices industry to join our team and contribute to the effective maintenance of our (MDR) ISO13485 certified Quality Management System and move us ahead with implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.
Key Responsibilities:
Responsible for managing or governing all QMS-related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Changes, Complaints handling, Recalls, Data analysis, Risk management.
Assuring production line compliance and working closely with the QA at the contracted manufacturer.
Ensuring compliance with in-house procedures through ongoing, periodic audits or inspections.
Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
Guidance by the Design and Development requirements per ISO13485 and Product Realization.
Maintaining design control activities by ISO13485.
Ensuring validation processes are performed and documented.
Provide support for risk analysis processes and technical file maintenance.
Working closely with the Medical Engineering team and R&D team
Making the quality world accessible to the Engineering and R&D team
Reports directly to the VP of Regulatory Affairs & QA

We are looking for an R&D Technician to join our top-talented multidisciplinary R&D team. The ideal candidate should be striving for the challenge of making a significant impact in a multi-disciplinary product in the med-tech industry; hands-on and highly technical.
The R&D Technician will provide diagnosis and analysis of all development aspects including solving technical problems.
Key Responsibilities:
Perform tests and Research (using JIGs, Apps, and specially designed tools).
Conducting electro-mechanical experiments for research, development, and validation.
Perform routine chemistry laboratory duties, such as weighing, and evaporating.
Working closely with the test and development teams.
Reading and writing reports related to R&D or testing.

We are looking for a Factory Engineer to join our production team.
As a Factory Engineer, you will ensure the continuous maintenance of manufacturing facilities in a clean environment.
Key Responsibilities:
Addressing production line malfunctions, equipment, and machinery.
Planning and managing a multi-year maintenance plan.
Overseeing calibration plans in the production department.
Performing preventive and ongoing maintenance.
Updating and maintaining engineering documents and records.
Planning the continuous improvement of the equipment and engineering processes.

The production team is looking for Assembly and calibration Technician to join the integrated metrology line and work on state of the art tools in the semiconductor industry.
Youll be joining the Production group under the operation division as an assembly technician. Your role will be to manufacture the company products while maintaining highest quality and on-time delivery.
As part of your job you will interact and work with the integration and Engineering departments to troubleshoot complicated mechanical and optical problems to produce the measurement unit.
Responsibilities:
Assembly and test systems containing optical, mechanical and electrical components in accordance with our Delivery plan.
Working in an organized way using digital procedures and flow management system.
Strive to high Quality in all production aspects and on time delivery.
Always striving to reduce cycle time and improve working process.
Actively involved in Transfer to Production (TTP) projects.
Collaborate with assembly team members to produce measurement unit.
Working in a clean room environment.

The service team is looking for a service product expert to provide global product support.
In this role you'll be joining the Global Service Group.
Our team provides service to a large-scale install base, at leading semiconductor manufacturers worldwide.
As part of this role you will be responsible for training, installation, and support of all products across customer sites globally.
We foster teamwork, excellence, and innovation, making customer success our main goal.
Responsibilities:
Serve as the central point of contact (Tier-3) for addressing all technical service needs related to our products.
Involved in product development activities; make sure field and customer needs are well-represented and prioritized during the product roadmap
Lead all field technical escalations
Actively participate in product evaluations
Proactively generate knowledge transfer sessions and on job training for FSEs worldwide
Develop and document procedures to install (start-up), retrofit and maintain the product (Technical Product Manuals) to improve field knowledge and performance.
Partner with engineering and product development to review and address Top Field Issues.
Develop new procedures, Service Notes, and troubleshooting guide as required.

The home tool team is looking for home tool Engineer.
Youll be joining the home tool team under the operation division as home tool Engineer. Your role will be to provide service and maintain the HQ home tools in order to achieve highest tool availability.
As part of your job you will interact and work with different tools owners: R&D and QA and ENG to provide fast support to tool problems
Responsibilities:
Maintain and service HQ home tools.
Install new home tools, perform ATP and report any failure during the installation.
Provide support for any unexpected failure (troubleshoot, repair, part replacement)
Execute PMs according to plan and as required.
Handle tools down in urgent mode to avoid delay in HQ planned activities.
Implement ECOs/CIPs per tool owners request within agreed time.
Home tools relocation plans move and reinstall.
Maintain the network and anti-virus based on HQ and IT policy.
In charge of home tool material/Safety stock - Material order and control (new and repair)
Manage with relevant stakeholders updated tool mapping and status in order to have full customer satisfaction.
Make sure that all labs are organized and safe to work in and have periodically tours with production manager to assure no safety hazards.
Present quarterly summary for all activities in defined formats

HW Project Team is looking for a Module Owner to lead and manage HW development in cross-platform HW functions.
Responsibilities:
Youll be joining the HW Project team:
The HW project team is part of R&D HW platform group that includes multi- disciplinary teams of Mechanic, Electric, Motion, Optic and Physic groups that responsible to all HW developments in םור measuring Instruments.
The module owner is a professional role in the HW group, supervising the development and the serial production readiness of multi-disciplinary HW systems and cross-platform HW functions.
The module owner is responsible for the compliance with requirements, the quality, and the productization of his/her assigned modules through managing plans and maintaining the required collaboration between all related organizational functions.
As Module owner you will:
Own the modules plan and the modules deliveries according to plan starting with requirements, throughout development, and ending with mature delivery.
Assure conformance and traceability between system requirements and HW requirements.
Prepare and present the major technical reviews of the module during development phases (HW requirements review, Critical requirements review, etc.).
Map the risks associated with meeting the modules plan objectives and own the plan for resolving them.
Solve unexpected issues, make timely decisions, and define the trade-offs to keep the timeline.
Lead and synchronize the HW teams tasks to meet the plan objectives.
Collaborate with project management and organizational stakeholders during the HW development process.