לוח משרות דרושים מכשור רפואי

As QMS Compliance Engineer you will be responsible for driving and supporting CT/AMI QMS compliance to international medical device regulations, ISO13485, and general quality system requirements. Additionally, you will be responsible for managing and monitoring CAPA activities.

Your role:

Ensure readiness for External Audits.

Support of the execution of external audits, internal audits and inspections including FDA, Notified Body and other 3rd party audits in CT/AMI.

Execution of internal quality audits.

Assists organizational units in addressing compliance deficiencies.

Global facilitation of the CAPA process per all relevant procedures.

Be the center of knowledge for all the CAPA practices and the Trackwise tool.

Support and present CAPA during internal and external audits successfully.

Provide other compliance support, including reviewing audit reports, including correct findings classification, and responses to audit findings for completeness and effectiveness and providing training on key compliance topics.

Support tracking and monitoring of audit finding action plans until closure, including assistance in the resolution to closure.

Support tracking and monitor key performance indicators (KPIs) and implement corrective actions as required.

Perform analyses and continuous monitoring in support of internal audits, management reviews, and external audits.

Supports the implementation of the Business long-range quality, regulatory and compliance policy. Supports managing plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of transitions.

As Clinical Development Scientist you will develop the clinical evidence strategy, execution and dissemination in support of assigned CT-AMI programs. You will provide input to the cross-functional team through strong critical scientific thinking to develop innovative solutions for evidence strategy development.

Your role:

Leading development of evidence generation strategies of assigned projects, working within a cross-functional team.

Creating subsequent clinical development / evaluation plans.

Developing strong collaboration with KOLs and Investigators.

Participate in the interpretation & dissemination of evidence generated from clinical evaluation plans such as Clinical Study Reports and Clinical Evaluation Reports.

Supporting clinical evidence discussions with regulators, advisory boards, associations and societies.

Highly skilled and motivated Quality Design Engineer to join our dynamic team in the medical device industry.

The ideal candidate will have a strong background in design control, quality assurance, and regulatory compliance, with the ability to work collaboratively with R&D, Engineering, Regulatory and other teams.
Adaptable and possess a deep understanding of the regulatory landscape governing medical devices, specifically experience in all phases of product life cycle (design, development, risk management, design verification, production) in adherence with ISO13485:2016, 21 CFR 820 and ISO14971.
Main Duties:
- Lead and implement design control and production processes to ensure compliance with industry standards and regulations.
- Lead proactive design assurance activities facilitating the development and release of high-quality products.
- Collaborate with cross-functional teams to integrate quality into the design and development and manufacturing process.
- Stay abreast of evolving regulatory requirements for medical devices and ensure the company's adherence to relevant standards.
- Work closely with R&D teams to understand design requirements and provide quality engineering input throughout the product development lifecycle.
- Conduct design reviews to identify and address potential quality issues early in the process.
- Responsible for reviewing, providing input and approving product development DHF documentation (design planning, inputs and outputs, design review, V&V protocol -reports, risk analysis, and design change, product transfer to operations, etc).
- Responsible for approval of product design changes and process changes (ECO).
- Participate in Design Reviews for product teams as the quality expert, reviewer, and approver.
- Implement risk management processes and methodologies in the design and development phases per ISO 14971.
- Participate in risk assessments and develop strategies to mitigate potential risks.
- Establish and maintain quality assurance procedures to ensure product quality and regulatory compliance.
- Conduct audits and assessments to identify areas for improvement and implement corrective actions.
- Conduct Failure investigations for Complaints and CAPA.
- Responsible for approval of equipment qualification and process validation documents (pFMEA, IQ, OQ, PQ, etc).
- Perform supplier audits and provided support in preparation and performance of external audits to ensure quality and regulatory requirements are met.
- Support continuous improvement activities to reduce product failure rates.

We are looking for a Site Technology Administrator who will be responsible for leveraging the resources and capabilities of the IT organization to enable business success across sites and regions while exemplifying the mission, values, and goals of the Enterprise Technology Office.


The Site Technology Administrator actively partners with our business units and fellow Enterprise Technology departments across their site and region of responsibility emphasizing quality and timely response.
This is a full-time, exempt, office-based position, fully on-site based in our Haifa, Israel office location.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Manage the day-to-day functions of the site technology and local IT hardware inventory.
Identify and track site issues and risks.
Participate in site-related expansions moves, and projects.
Foster and maintain relationships by engaging business leaders, teams, and end-users.
Provide support and solutions to all personnel on-site and at their remote locations.
Promote an environment that encourages information sharing and focuses on prompt and effective end-user issue resolution.
Facilitate employee onboarding and off-boarding.
Instruct users according to internal training, IT General Controls (ITGCs) and standard operating procedures (SOPs).
Monitor ticket queues to ensure incidents are being handled on a timely basis by the service desk, identify trends and escalations when needed, prioritize, communicate status, and work through to resolution in person, over the phone, and by utilizing remote tools when necessary.
Report the status of tickets to the Enterprise Technology Leadership Team.
Manage local technology vendors, and ensure resolution and SLAs are achieved by managed service providers.
Serve as a local contact for technology service providers such as internet service providers, mobile phone and network providers, and technology-related hardware providers at the site.
Work independently to complete assigned individual projects, tasks, or other ad hoc duties as assigned.

We are looking for a highly motivated and professional Senior Experimental Physicist for a full-time position, to be part of our physics group in our R&D center.


Our physics group is leading an effort to develop a new field of research:
Tumor Treating Fields (TTFields) dosimetry and treatment planning, and currently specializes in numerical simulations, physical algorithms, data analysis, and biophysics-based research.

In this position, you will be responsible for driving and performing experimental research and development at the interface of physics and medicine, in the rapidly developing field of TTFields.







ESSENTIAL DUTIES AND RESPONSIBILITIES:

Drive the experimental research and development activities in the group, with a focus on TTFields delivery optimization and simulation validation.
Develop the experimental methods and infrastructure for:
Validation of electrical and heat-transfer simulations.
Characterization of electric properties of tissues.
Development of physical phantoms for investigating electric field and thermal distributions.
Participate in research and development collaborations with internal groups of engineers and scientists, and with external researchers from academia.
Present results at internal meetings, seminars, and external scientific conferences; contribute to writing scientific papers and patent applications.
Participate and support team efforts to develop the next generations of devices and treatment-panning platforms for TTFields therapy.
Actively support other R&D activities in the physics team, including fundamental research in theoretical biophysics and dosimetry.

Business Development Manager:
We are a leading global medical device company, is seeking for a business development leader. To grow our direct sales via marketing campaigns, collaborations, KOLs, local events, and process optimization.
Responsibilities-
* Lead team of inside sales reps.
* Create relationships with KOLs
* Generate opportunities for the sales team by researching and targeting specific industries, accounts, groups, personas.
* Collaborate with sales and marketing teams to optimize global marketing campaigns.
* Build strategy for brand awareness and leads generating in new markets.
* Manage monthly/quarterly sales reports, pipelines, forecasts. Monitor weekly goals and metrics: calls made, emails sent, accounts touched, etc.
Submit your resume toour e-mail.
Job number must be specified.