we aim to improve patient outcomes by empowering every gastroenterologist across the globe with artificial intelligence and disruptive therapeutic technologies.

In this exciting role as an Operation Quality Engineer, you will directly support the day-to-day Yokneam products manufacturing, transfer, and improvements activities. You will have the opportunity to drive a culture of continuous improvement by deploying sound engineering fundamentals to achieve quality objectives and ultimately yielding better patient outcomes.

A Day in the Life
Communicate quality standards and requirements within the organization and collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
Oversee and participate change approval process (risk assessment, verification, validation).
Lead Quality Assurance and product quality improvements in cross-functional initiatives. Ensure that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
Collaborate with global Operations, QA, Engineering and Manufacturing to ensure quality standards are in place and support day-to-day manufacturing activities.
Specialize in the areas of production control, incoming material, product evaluation, and reliability, inventory control, and development as they apply to product or process quality.
Take an active role in leading and reviewing design and manufacturing changes and lead product quality investigations in support of CAPA, complaints and non-conforming material processes and lead Quality Assurance and product quality improvements in cross-functional initiatives.

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 Design Control Manager to join our rapidly growing team. You will play an essential role in reviewing, and approving design & development, design changes, and implementation (production) processes, executing risk-based product controls.
You will be the contact person for quality-related issues for the different R&D teams and closely work with V&V / SQA, R&D, Project leads, and Product.
You have solid experience with working in the crossing between RA R&D QA and are comfortable ensuring compliance in the teams projects where the focus will be on Design Control.
The position will also encompass related areas of responsibility such as supporting work with CAPA, implementing new standards, and participating actively in audits.

Mechanical Engineer within the Urology Division will be responsible for providing support for released products within the Laser Franchise, which consists of Holmium and CO2 laser capital systems, laser fibers and associated accessories.

Mechanical Engineer works in close collaboration with the different technical disciplines (Elec, Mech, SW, Physics), as well as the other cross-functional groups (Quality, Regulatory, Manufacturing, Service) to support sustaining activities as part of Product Life Cycle.

Mechanical Engineer supports growth of products to new markets and leads design changes originating in product improvements, regulatory or supply chain needs.

Main Duties:
Conduct root cause analysis of design related field complaints.
Lead product improvement design activities.
Provide technical assistance for sales and marketing activities.
Support the integration of acquired assets within the laser franchise into the company`s Scientific quality system.
Work in collaboration with Regulatory team to provide and maintain the regulatory design inputs and systems compliance. Own the transfer from regulation/standards to engineering derivatives (impact assessment and deployment).
Support RA team with new markets registrations and regulatory submissions.
Definition, writing and management of Design Inputs and flow down for the sustaining products.

n this role, the QA Engineer supports products development and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.

The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.



Essential Duties and Responsibilities:

QA focal point for R&D projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
Responsible for final approval of R&D documentation- reviewing and approving technical and DHF documentation.
Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
Responsible for approval of product design changes
Finding solutions for queries within responsibility limits
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in product development design reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
Attend program meetings as required as part of extended program teams

Required Global Engineering Manager.
Objectives:
Management of the designs teams in HQ and coordination of the engineering system activities: product engineering, manufacturing engineering, configuration engineering, electrical engineering, technology, and regulation.
Developing and implementing engineering strategies that align with overall business objectives and market trends.
Professional guidance in manufacturing engineering for various territories and ensuring that production is carried out using the same methods and standards.
Collaborating with other departments such as product management, sales, and marketing to ensure engineering efforts support company-wide initiatives.
Implementing processes and standards to maintain high-quality production of company's products.
Providing quick and accurate responses to the sales, marketing, and operations departments to meet the company's goals.
Defining and leading engineering workflows: item and product infrastructures, change management, NPI processes.
Managing workflow routines in interfaces (marketing, sales, and operations).
Setting objectives and key performance indicators (KPIs).
Member of the operations management team.
Responsible for managing the global engineering managers forum.

A Global medical high-tech Company located in Shoham, is seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy.
Responsibilities & Scope of work:
Supports and maintains EU- MDR submission related activities (QMS, Technical Files, GSPR and PMS) and liaises with regulatory authorities
* Participation in internal and external audits e.g., FDA, Notified Body etc. for regulatory affairs matters - Oversight and performance of routine QA activities such as: ECO, MRB, NC, Monitoring of Calibrations, Training and Qualification, Customer Complaints, CAPA, Document and Record Control, Approval of qualification and validation activities etc.
* Control of processes in compliance with the applicable regulations and company procedure requirements - Participate in Management Reviews and analyze quality data
* Work closely with R&D through product development process and design activities.
* Support risk management activities including hazard analysis and FMEA. - Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.
* Support and improve company Quality Systems by creating a quality culture and provide ongoing education on compliance activities.
* Contribute towards accomplishment of departmental and corporate goals and objectives
* All other duties as requested by his/her manager.

* Executed risk analyses with control plan (PFMEA)
* Plan, control, and assure product and process quality in accordance with quality principles
* Implement effectively, professional tasks in the areas of quality assurance and regulations.
* Oversee production quality processes, including contract manufacturers.
* Support company failure investigation, CAPA, MRB, audits as required
* Define and implement KPIs for the internal teams in Quality reliability and functionality .
* Perform periodic analysis of KPIs and build improvement plans

Required Quality Engineer Production
Beit Shean
Description:
Executed risk analyses with control plan (PFMEA)
Plan, control, and assure product and process quality in accordance with quality principles
Implement effectively, professional tasks in the areas of quality assurance and regulations.
Oversee production quality processes, including contract manufacturers.
Support company failure investigation, CAPA, MRB, audits as required
Define and implement KPIs for the internal teams in Quality reliability and functionality .
Perform periodic analysis of KPIs and build improvement plans.

We are looking for a talented Quality Engineer, who will be responsible for the implementation of effective quality controls, inspection methods, and evaluation of the reliability of manufacturing processes, products, and production equipment. Joining the team means being part of an elite group of innovators with a passion for creating future-defining and groundbreaking technologies that shape our everyday lives.

Responsibilities:

* Implement effective quality controls, teach production staff how to use them, and supervise outcomes.
* Implementing inspection methods and evaluating the reliability of manufacturing processes, products, and production equipment.
* Preparing the company for quality audits of customers and international standardization organizations.
* Led CAPA and Root cause analysis, and responsible for task management.
* MRB - Management and tracking.
* Responsible for the company's calibration system.
* Monitors suppliers performance and reports key process indicator to upper management.
* Working in accordance with deadlines for delivery of products.
* Leading certifications of products for new standards & regulations.