We are looking for a highly motivated, energetic, and people-oriented professional for a full-time position as a Device Support Specialist for Israel (field-based).



The Device Support Specialist will be joining a team of technicians and support representatives from other regions/countries.


The Device Support Specialist will support commercial and clinical trial patients utilizing the Medical Device for treating cancer diseases.







ESSENTIAL DUTIES AND RESPONSIBILITIES:

Perform patient and caregivers training on the Optune Medical Device or the TTF100/200A.
Reinforce and adjust patient training on at least a monthly basis as applicable.
Conduct regular patient visits to check the technical status of equipment and replace components as necessary.
Troubleshoot problems through a well-defined procedure.
Work closely with the Israel Sales Team, the European Clinical Team, Technical Support, and Commercial Operations, as well as Global Operations Center.
Take part in regular team meetings in person and on Teams
Travel to patient homes and Hospitals. (up to 60%70% travel)
Must have the flexibility to help in remote areas throughout Israel to help out colleagues
Keep a high level of training and knowledge updated through a deep understanding of position-related SOPs.
All approved travel expenses will be reimbursed.
The amount of travel required is dependent on patient needs and location, but could be as much as several hours per day.
Ensure activities comply with the applicable Quality System requirements.
On Call for patients after hours
Main area of travel needed: Jerusalem area and North of Israel, in certain specified areas

In this onsite role, the Team Leader Quality Operations leads a team of Quality Engineers that support manufacturing processes and projects, as well as provide quality oversight to the Engineering department within a multi-functional team environment for medical devices. This Team Leader will lead QEs, projects and tasks, from product inception through commercial product and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all applicable regulatory requirements. Additionally, this role will identify and implement improvements within the Quality Management System. The Senior Quality Engineer will be a strong advocate for product, process, and system quality at all stages of manufacturing processes.

Essential Duties and Responsibilities
Exhibit a strong quality first mentality and ensure that products, processes and quality are held to the highest standard, adhere to all company policies, KPIs and follow all safety rules and safety procedures
Lead QEs daily activities, provide support, guidance, set objectives, monitor performance, and follow-ups as required.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
Responsible to provide support to manufacturing related processes, such as (but not limited to) approval of equipment qualification, process risk management and pFMEA, and process validation documents (URS, IQ, OQ, PQ, etc.), and responsible to review, and approve product development DHF documentation (product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, OOSs, product transfer to operations, etc.) in relation to medical devices.
Lead the Quality involvement in development and maintenance of product and hazard analysis in accordance with West policies and procedures.
Provide Quality oversight of qualification/validation/review and approval of documentation and reports/design controls activities to other QEs
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects.
Responsible to review and approve process development QMS procedures and work instructions and support QMS activities as required.
Liaison with company and customers on Quality matters related to engineering projects.
Support routine sterilization validation monitoring activities.