לוח משרות דרושים בטירת כרמל

The job holder’s duties and responsibilities include any of the following:
* Act as Insightec Quality Management Representative
* Responsible for the Insightec quality management system
* Lead the Quality Assurance team
* Lead the company to meet its annual quality goals
* Lead quality data analysis
* Update company management on quality performance and policy implementation
* Define and maintain quality aspects processes for relevant quality related Insightec activities
* Lead and ensure company compliance with quality standards and certifications as required
* Lead and prepare the company for internal and external auditing authorities as required
* Support company teams with QA requirements and processes
* Act as the person responsible for regulatory compliance (PRRC)

Advantages::

* Formal Auditing Conductance training

* Writing, reviewing, and performing design verification tests for company's products, manufacturing equipment and test benches
* Participating in design reviews and providing input on requirements, product design, and potential problems
* Writing the test results, analyze statistical data, maintaining test records in compliance with company's QMS and applicable standards/regulations
* Writing and maintaining traceability documents to cover SW/System requirements and functional specifications
* Logging defects and writing clear and concise bug reports using defect tracking software tools

Advantages::

* Experience in working with tools, such as: Oscilloscope, DMM, Jama, Jira, LabView, signal generators
* Experience in developing and running automation tests, working experience with C#, Python, Autoit, PowerShell
* Experience in working with software and hardware development, project management, service engineering to understand the expected product functionality and customer requirements
* Experience in medical device product testing
* Experience in testing automation

* Serve as right-hand finance business partner to Chief Operations Officer, supporting the established strategic goals.
* Manage and analyze operation functions (Manufacturing, Supply Chain, R&D, IT and Facilities) financials and non-financial metrics, including forecasts and actuals, scenario planning at the level of a public company.
* Develop efficient planning and reporting processes to methodologies and record individual R&D programs for financial performance and milestone timelines.
* Support cross-functional projects aligned with strategic initiatives.
* Support a potential IPO.
* Analyze business performance to generate insights that support growth, operational efficiency and goal achievement.
* Support the Production of board of director presentations for the operation activities.
* Provide insights and analysis for decision support for COO leadership team.
* Forecast and budget expenses for partnered functions.
* Manage a small team responsible for supporting the COO

What you will be doing:
* Provide regulatory support to the Development and Post marketing activities related to our products.
* Preparation and maintenance of regulatory submissions and registrations of our products in relevant markets.
* Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
* Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
* Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
* Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
* Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations
* Provide support for all external/internal audits at HQ and globally, as needed
* Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
* Work closely with various other teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
* Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance
* Attend other regulatory related needs, as required
* Working according to our Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

What you will be doing: Salesforce Admin: Manage Salesforce configuration, maintenance, and enhancements to support business needs. Suggest out of the box solutions and support the Service Cloud, FSL and Salesforce mobile app. Implement & Optimize Information Systems : Lead the deployment of digital solutions, including new technologies or enhancement of current digital tools, while ensuring alignment with business requirements and IT best practices. System Integration: Develop and manage integration between various applications, ensuring seamless data flow and operational efficiency; using iPaaS integration tools such as Workato or different integration methods. Automation & Efficiency Improvements: Identify opportunities for automation, implement workflow optimizations, and reduce manual efforts through innovative solutions. Project Management: Oversee information system projects from inception to completion ensuring timely and successful delivery; Including timeline and budget management, project documentation and meeting security and compliance standards. Technical Support & Troubleshooting: Provide technical expertise and troubleshooting support for application-related issues, ensuring system reliability and performance.


Advantages::

* Familiarity with Priority-ERP – advantage

What you will be doing
Production Planning, develop, monitor and update detailed production plans to ensure timely completion of production schedules. Coordinate with production team to align resources and timeline. Material Coordination, ensure material availability for production by coordinating with procurement and warehouse teams. Report material shortages for the short -term production, track and follow up. Subcontractor Management, build and manage detailed production plans including forecast for subcontractor, ensuring alignment with overall production schedules. Capacity Planning, evaluate production capacity and recommend adjustments to meet short-term and long-term goals. Identify bottlenecks and implement solutions to enhance efficiency. Engineering Change Orders (ECO), implement and execute the material related aspect for ECOs in the production workflow and inventory. Inventory Management, Implement and maintain inventory methodology principles for efficient material usage.
* Working according to our Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.