Careers

Join us for a
life-saving mission

Developing an innovative analytics solution that alerts clinical teams about a patient’s deterioration, enabling early intervention and improving clinical outcomes

POSITIONS AVAILABLE

QA&RA Expert

Netanya, Israel · Full-time

About The Position


  • Defining, implementing, managing and controlling Clew Medical Quality System for compliance with the requirements of ISO13485, and USA 21 CFR§820 Quality and Regulation and IEC 62304- Software life cycle processes system.
  • Support the regulatory activities for new and existing products including regulatory submissions (FDA, CE, AMAR).
  • Guiding R&D, Marketing, Clinical personnel as well as subcontractors regarding quality and regulatory requirements.
  • Manage Engineering Change Orders (ECO) – initiate and manage software change orders.
  • Managing Customer Complaints process and customer’s DHR
  • Managing yearly ISO audits, ongoing DHF and CAPA process

·      Maintain and update the Approved Supplier List (ASL)

  • Support Reporting products changes to regulatory bodies as required.
  • Reporting incidents (adverse events) to the applicable regulatory bodies/agencies
  • Reporting quality system performance to the company's management for review and initiation of improvement actions. (Annual management quality review)

Ensuring the promotion of awareness and training, of quality and of regulatory and customer requirements throughout the organization.

Requirements

·  B.A or B.Sc. degree in a relevant field

·   1-3 years Quality Assurance/Regulatory experience as QA/RA expert in the medical device company.

·  Knowledge in ISO13485, FDA QSR, and EU MDR requirements

· Experience with software medical device (IEC62304, SDLC)- is preferred.

·  Demonstrated knowledge of regulatory issues, and experience interfacing with local & international regulatory bodies, such as FDA, European

competent authorities & notified bodies, Health Canada, etc.

· Experience of routine QA activities: CAPA, MRB, ECO, Complaints etc..

· Demonstrated management skills; ability to prioritize, plan, evaluate & execute deliverables for established tactical goals.

· Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level

products & related processes.

· Proactive leader with strong ownership and excellent interpersonal relationships

· English Proficiency.

Why join our team?

At CLEW, you will have the opportunity to work alongside the world’s most talented researchers, data scientists, engineers, finance and sales professionals to meet the rising demand for high-quality care in today’s post-pandemic world. No matter what position you are in, you will become a full partner in our life-changing mission.

INNOVATION

Our emphasis on innovation encourages higher levels of creativity and out-of-the-box thinking that empowers our employees to reach their maximum potential. It has also enabled us to fuse the highest standards of care with the latest ML/AI tools to redefine the future of critical care.

A healthy work/life balance

We believe that quality time outside of the workplace is vital to our employees’ mental health and overall satisfaction. At CLEW, we encourage flexible scheduling, company-sponsored health initiatives, and giving back to our communities through volunteerism.

Company stage

Our Virtual ICU product is deployed in some of the leading critical care facilities in the US and we have strong financial backing from Israel’s leading venture capital funds. We are at a critical stage in product development and are looking for people to join the team who are as excited as we are.

Work space and environment

We believe that an engaging and convenient work environment is necessary to foster communication and productivity. We work hard together, and play hard together too. Luckily, at CLEW, there are no shortage of reasons to have fun and celebrate together.

Dynamic Environment

An engaging work environment with an emphasis on convenience and creativity to foster communication and productivity.

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Patient View
Rapid, clear, consistent patient data summary and visualization

  • Patient risk stratification (high, moderate and low risk patients)
  • Intubated patients
  • Vasopressors/inotrope support
  • Empty beds
  • Key patient and unit information
  • Occupancy, ventilator status and vasoactive medication
  • User selectable vital sign display
  • Summary of all relevant lab results
    Dynamic and collaborative caregiver task list
  • Aggregate patient demographicsand PMH (past medical history) andpredicted risk level

Patient View
Rapid, clear, consistent patient data summary and visualization
High Risk Patients

  • Tasks
  • New Admissions (pulled from a left sidebar)
  • User selectable vital sign display
  • Summary of all relevant lab results
  • Dynamic and collaborative caregiver task list
  • Aggregate patient demographics, PMH and risk level

Unit View
Full TeleICU situational awareness, displaying patient data and predicted state from all units and highlighting all notifications

  • Patient risk stratification (high, moderate and low risk patients)
    Intubated patients
  • Patients on vasoactive medication
    Unit occupancy
  • Patients on vasoactive medication
  • High-level estimation of the overall unit acuity

    Key patient and unit information

     

Work List
Integration with the TeleICU workflow by gathering all notifications, tasks, new admissions and high-risk patients

  • Notifications
  • High Risk Patients
  • Tasks
  • New Admissions (pulled from a left sidebar)

Unit View by Layout

Full ICU situational awareness, displaying patient data and predicted risk level, for one unit or multiple units. The display highlights all notifications, low risk patients and other key clinical information, to provide multi-dimensional situational awareness.

  • Patient risk stratification (high, moderate and low risk patients))
  • Intubated patients
  • Vasopressors/inotrope support
  • Empty beds
  • Key patient and unit information
  • Occupancy, ventilator status and vasoactive medication
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