לוח משרות דרושים מהנדס איכות משרה מלאה

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging whats possible and making headway to help improve outcomes.
The Quality Engineer II oversees the execution of the quality plans ensuring product realization is conducted in compliance with internal, customer and regulatory requirements during all phases of the product lifecycle. Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, this position:
This role will be based in Haifa following our planned office relocation in 2026.
Reviews new and modified product design and manufacturing processes for quality characteristics, including manufacturability, serviceability, testability, reliability and conformance to product and quality system requirements.
Develops and manages the product risk management process, including the development and maintenance of risk management files.
Qualifies component and service suppliers, conducts supplier audits and ensures that appropriate supplier quality controls are implemented.
Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects.
Provides guidance to R&D, Operations and Quality on design and production/process controls, risk management, root cause analysis, validation and the application of statistical methods.
Host business meetings with other functions within the organization including but not limited to Training, Human Resources, Manufacturing and Research and Development.
May manage projects that involve other functions within the organization including but not limited to Training, Human Resources, Manufacturing and Research and Development.
Responsible for communicating business related issues or opportunities to the next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.

We are seeking a highly motivated and detail-oriented Production and Supplier Quality Team Leader . This role is responsible for ensuring the
highest quality standards in production and supplier-provided components, driving continuous improvement, and maintaining compliance with
medical industry regulations.
Key Responsibilities
In this role, you will
Lead and manage the Production & Supplier Quality team.
Develop and implement quality control processes for materials and products.
Collaborate with suppliers on quality agreements, audits, and corrective actions.
Oversee incoming inspections and ensure compliance with ISO 13485, FDA, MDR.
Drive continuous improvement using Six Sigma, Lean, RCA.
Conduct internal/external audits and manage CAPA, NCR, and risk documentation.
Mentor team members and foster a culture of quality excellence.

Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
Key Responsibilities
In this role, you will
Daily duties include supporting the project team (R&D, SQA, Product, System and so on) during the development of a project. Our engineers review each design input and output deliverable throughout the development process and resolve compliance impediments as they arise. As a senior engineer the candidate will be responsible for defining two major evolving components in our work:
Implementing AI in our processes - What are the regulatory requirements for implementing AI in a medical device and how to implement it in our development lifecycle.
Cybersecurity work instructions in compliance with the new FDA guidance, train the various teams on the guidance and its implications to our process, and establish best practices for supporting post market vigilance.

Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
Key Responsibilities
In this role, you will
Daily duties include supporting the project team (R&D, SQA, Product, System and so on) during the development of a project. Our engineers review each design input and output deliverable throughout the development process and resolve compliance impediments as they arise. As a senior engineer the candidate will be responsible for defining two major evolving components in our work:
Implementing AI in our processes - What are the regulatory requirements for implementing AI in a medical device and how to implement it in our development lifecycle.
Cybersecurity work instructions in compliance with the new FDA guidance, train the various teams on the guidance and its implications to our process, and establish best practices for supporting post market.

we are a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. Were looking for a QA Engineer to support and strengthen our manufacturing quality. In this role, youll work closely with cross-functional teams, execute day-to-day quality activities on the manufacturing floor and help drive continuous improvement in a hands-on, fast-paced environment.
LOCATION: Yokneam, Israel.
SCOPE & RESPONSIBILITIES
* Manage ECOs: conduct risk assessments, update relevant DMR documents and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks.
* Manage DCOs in the PLM system : Write and update QA procedures to ensure compliance with quality standards and regulatory requirements.
* Manage NCR and CAPA processes: Lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions.
* Manage QA production activities: Provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality.
* Ensure Timely Resolution of Quality Issues: Promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations.
* Participate in audits: Take part in internal and external audits, such as FDA inspections and notified body audits based on ISO13485, EUMDR, and MDSAP requirements.
* Manage Supplier quality: Manage supplier qualification and performance monitoring, including SCAR management, and support supplier audits.

Responsibilities:
Review of Contract ,Customer SOW and SPEC requirements to ensure compliance of design and production.
Approve gates review at R&D
PLCM (Project Life Cycle Management) - process control, full partnership in project management during the development, testing, production, customer delivery and customer support phases throughout the product life
Identifying regulatory Gaps in new and carrent projects
Perform Internal and External Audits
QA presence in R&D process (capacity) and ability to prevent errors in design
Follow up after R&D corrective and preventive actions and Improvement Plans
Transfer products from development to NPI and serial production (QA activities)
Review and approval ECO / MCO / ATP/ATR, Waiver relate to R&D , ENG
Writing QA procedures
FRACAS Management
Quality Assurance Program Plan (QAPP) and the Quality Allocation Tasks for the program.
Customer complince - relate to NPI , Pre production , design errors
Perform Quarterly data analysis for QBR.

As a Quality and Reliability (Q&R) Engineer, you will lead the qualification and long-term reliability of advanced System-on-Chip (SoC) and RF semiconductor products for automotive applications. Youll work across digital and RF domains to ensure robust performance and compliance with industry standards.
What will your job look like:
Define and manage Quality and Reliability specifications, simulations, and qualification plans for SoC and RF die and package.
Plan and execute automotive-grade qualifications per standards such as AEC-Q100, JEDEC JESD22, and IATF 16949.
Design and implement die-level and package-level stress tests.
Select and prepare electrical, environmental, and mechanical test platforms for reliability testing.
Define requirements for Pre-Si Q&R (e.g. ESD, LU, EM, IR drop), Design-for-Test (DFT), electrical characterization, and Post-Si Q&R testing of digital, mixed-signal and RF SoCs.
Collaborate extensively with internal design teams, external subcontractors, and outsourcing partners (OSATs).
Lead failure analysis, reliability modeling, and corrective action processes (e.g., 8D, FMEA, FMEDA).
Document and certify automotive standards compliance, including PPAP/APQP deliverables.

As a Quality and Reliability (Q&R) Engineer, you will lead the qualification and long-term reliability of advanced System-on-Chip (SoC) and RF semiconductor products for automotive applications. Youll work across digital and RF domains to ensure robust performance and compliance with industry standards.
What will your job look like:
Define and manage Quality and Reliability specifications, simulations, and qualification plans for SoC and RF die and package.
Plan and execute automotive-grade qualifications per standards such as AEC-Q100, JEDEC JESD22, and IATF 16949.
Design and implement die-level and package-level stress tests.
Select and prepare electrical, environmental, and mechanical test platforms for reliability testing.
Define requirements for Pre-Si Q&R (e.g. ESD, LU, EM, IR drop), Design-for-Test (DFT), electrical characterization, and Post-Si Q&R testing of digital, mixed-signal and RF SoCs.
Collaborate extensively with internal design teams, external subcontractors, and outsourcing partners (OSATs).
Lead failure analysis, reliability modeling, and corrective action processes (e.g., 8D, FMEA, FMEDA).
Document and certify automotive standards compliance, including PPAP/APQP deliverables.

The MEQ (Quality) team is responsible to foster quality and excellence in products and processes across the entire company. MEQ team focuses on ensuring high customers' satisfaction through continuous improvement and implementation of automotive standards and best-practices such as ASPICE, IATF16949, ISO 9001, VDA/AIAG Core Tools and ISO26262, both internal and across the entire supply chain, In order to support MEQ objectives, The QMS & Production Quality team is looking for a Production Configuration Manager.
What will your job look like:
Define and implement cross company configuration and change management process, incl: KPIs, Inputs, Outputs, Control points, Reports (from scratch)
Work closely with colleagues from other departments (PMs, development engineers, production engineers, management) and other organizations (suppliers and customers) to realize relevant activities.
Define work items/products release process.
Manage and verify retention, back-up and recovery of company products/projects work items.
Create, manage and update PPAP folders for company products.
Identify opportunities for improvement and execute them.
Create relevant work items templates and coach the team how to use them.
CCB team - Lead/participate.
Support configuration & change related issues with customers, suppliers and 3rd party organizations.

מהנדס איכות, הסמכה ועמידה ברגולציה- לחברת הייטק בשדרות: The Quality, Certification & Compliance Engineer is responsible for ensuring that products, processes, and
systems meet internal quality standards as well as external regulatory, safety, and certification requirements.
This role bridges engineering, manufacturing, and regulatory bodies to ensure compliance throughout the
product lifecycle-from design and development through production and deployment.
The engineer leads certification efforts, maintains compliance documentation, supports audits, and drives
continuous improvement initiatives to enhance product quality, reliability, and regulatory readiness.



Key Responsibilities
Develop and implement quality control processes and procedures. Inspect, TEST, and analyze products to ensure compliance with standards. Lead certification activities for the systems, sub-assemblies, and components. Ensure compliance with relevant international standards (UL/ ETL, CE, IEC, ISO, ASHRAE, RoHS, REACH, WEEE, etc.). Coordinate with testing laboratories and certification bodies worldwide. Work with production teams to resolve quality issues. Ensure compliance with industry regulations and company policies. Analyse data to identify trends and areas for improvement. Train employees on quality standards and procedures. Collaborate with suppliers to maintain quality in raw materials and components.

Design Quality Engineer Responsibilities Lead quality oversight of hardware and system development processes across the product lifecycle

As a Quality Engineer in Manufacturing, you will play a key role in ensuring that products are manufactured in compliance with internal quality standards, regulatory requirements, and our companys commitment to patient safety and product excellence. This position partners closely with Manufacturing, Operations, R&D, and Supply Chain to drive quality improvements and support continuous improvement initiatives on the production floor.
Responsibilities may include the following and other duties may be assigned:
Provide quality engineering support for manufacturing operations and engineering.
Support production, engineering, validation activities including training, reviewing and approving documentation, work instructions, SOPs , supporting risk assessments, to ensure compliance with regulatory and quality system requirements.
Lead and support investigations of nonconformances, deviations, and CAPAs, including root cause analysis and implementation of corrective and preventive actions.
Collaborate with cross-functional teams to identify, assess, and mitigate quality risks in manufacturing processes.
Support internal and external audits, including preparation, participation, and follow-up on audit findings.
Drive continuous improvement initiatives using quality and lean methodologies.
Ensure effective implementation and monitoring of process controls and quality metrics.
Support change management activities ensuring requirements are identified and executed when applicable.
Participate in Management Review and Quality Metrics reporting.

Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
In this role, you will
Daily duties include supporting the project team (R&D, SQA, Product, System and so on) during the development of a project. Our engineers review each design input and output deliverable throughout the development process and resolve compliance impediments as they arise. As a senior engineer the candidate will be responsible for defining two major evolving components in our work:
Implementing AI in our processes - What are the regulatory requirements for implementing AI in a medical device and how to implement it in our development lifecycle.
Cybersecurity work instructions in compliance with the new FDA guidance, train the various teams on the guidance and its implications to our process, and establish best practices for supporting post market vigilance.