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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.

A dynamic fast-paced start-up company, transforming the way reliability of electronics is achieved. In a world where machines are gaining immense responsibility over our lives, sudden failure is not an option.

We have developed a cloud-based platform, which combines data created in chip-embedded Agents (IPs), with machine learning, to predict faults before they become failures. Our solutions provide unprecedented insights throughout the value chain, from Chip Vendors to System Vendors and Digital Service Providers.

The company was founded by seasoned industry veterans, including three former founders of Mellanox Technologies, with deep knowledge and experience in the electronics industry and is backed by worldwide leading investors.

we combine different disciplines to create a revolutionary solution. Our team is highly interdisciplinary, ranging from SaaS and Machine Learning experts to top designers in Chips and Circuits, as well as masters of EDA. We work together and learn from each other.

We are looking for a CAD Engineer with backend physical design experience to join our team.

The Global Cost Analyst provides an extensive support to R&D, Procurement and Operations leaders in order to help drive cost reduction and improvement in the short and long term.

Your role:

Single point of contact for integral landed cost calculations (Actual, forecast) for both mature and new products of the CT/AMI global portfolio.

Partner with R&D, Procurement and Operations leaders in order to help drive cost reduction and improvement in short and longer term.

Key role in validating and tracking BOM savings and their translations the BU P&L.

Consult and optimize strategies to improve landed costs across the different sites and product lines.

Periodically present landed costs results, forecasts, high/low lights to upper management.

Manage all related product data bases (Different SAP systems/databases ZDVC, ZFFP, etc).

Serve as Factory Cost Price (FCP/FSP) expert for BU with internal (BU) and external (our key markets, finance Center of excellence) parties on iCoS and related productivity.

Support with Month-End Close, Forecasts, and Annual Budgeting entries and analysis to support Operations & BU.

Working together with Operations for analysis of absorption with understanding of key drivers.

A dynamic fast-paced start-up company, transforming the way reliability of electronics is achieved. In a world where machines are gaining immense responsibility over our lives, sudden failure is not an option.

We have developed a cloud-based platform, which combines data created in chip-embedded Agents (IPs), with machine learning, to predict faults before they become failures. Our solutions provide unprecedented insights throughout the value chain, from Chip Vendors to System Vendors and Digital Service Providers.

The company was founded by seasoned industry veterans, including three former founders of Mellanox Technologies, with deep knowledge and experience in the electronics industry and is backed by worldwide leading investors.

we combine different disciplines to create a revolutionary solution. Our team is highly interdisciplinary, ranging from SaaS and Machine Learning experts, to top designers in Chips and Circuits, as well as masters of EDA. We work together and learn from each other.

We encourage you to apply for this exciting opportunity and play a leading role at Israel's most promising startup.