דרושים » ייצור ותעשייה » Design Quality Engineer

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.

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.

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.

The Senior RA specialistwill be responsible for leading global market expansion and new product introductions for Class I, Class II (US) and Class IIa (EU) medical devices. Responsibilities include planning and executing regulatory submissions for the US, EU, and other international markets, creating and maintaining technical files, managing complaints, overseeing change activities, and ensuring post market compliance. The role collaborates with cross functional teams - including QA, R&D, Clinical, Manufacturing, Operations, Marketing, and Commercial - to ensure compliant efficient, and timely market access throughout the product lifecycle, including sustained compliance.



Responsibilities:

Market Expansion & Global Regulatory Registrations

Prepare and maintain global regulatory submissions (e.g., India, Australia, Singapore, Mexico) and author full submission packages. (e.g., EU MDR Annex II/III TD, US 510(k), ANVISA, SFDA, NMPA).
Monitor regulatory changes and ensure sustained compliance across all markets, including labeling, UDI, and post-market updates.
Conduct jurisdiction -specific impact assessment for product changes and manage global propagation of design, labeling and UDI updates.
Collaborate with R&D, Operations, Marketing, and product teams throughout new product development and commercialization to ensure regulatory alignment
Review technical documentation and ensure compliance across the full product lifecycle
Serve as the QA/RA point of contact for cross-functional programs and regulatory-related initiatives.
Maintain existing registrations, manage renewals and variations, and oversee global portfolio compliance.
Develop and execute global regulatory strategies for new market entry (US 510(k), EU MDR, Canada MDL, LATAM, APAC, MEA), including interpret country-specific requirements, identification of testing and labeling needs, and creation of submission roadmaps.
Lead pre-submission meetings and manage interactions with health authorities and notified bodies.
Ensure compliance with ISO 13485, 21 CFR 820, EU MDR, and applicable country regulations.


Post-Market Activities

Develop, implement and maintain processes to ensure compliance with applicable regulatory standards and requirements
Maintain documentation and quality records in compliance with ISO 13485, QMSR,
and internal QMS (e.g., change management, technical file updates)
Support internal audits, management reviews, and quality improvement initiatives
Participate in risk management activities and lead or support CAPA investigations, nonconformances and root cause analysis
Serve as the companys Complaint Designated Unit (CDU), managing the full lifecycle of medical devices complaints, including trend analysis, investigations, and reporting to authorities.
Participate in external audits and inspection readiness activities
Conduct regulatory gap assessments and execute remediation plans (CER updates, PMS/PMCF plans, ISO 14971 risk management).
Drive closure of regulatory-related CAPAs and support audit and inspection readiness.
Manage post-market surveillance deliverables (e.g., PSUR, vigilance reporting) and ensure timely corrective actions.

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.

The Senior Product Quality and Reliability Engineer will provide leadership and management for the Networking system product quality within the organization. Establish, maintain, and optimize an effective quality management methods and target to achieve high quality performance.

As part of our team , you will work on networking system products and ensure their readiness for high-volume manufacturing. Leading and mentoring root cause analysis for issues related to design, manufacturing or customers. Enhance and improve products performance by proactive risk assessment and other prevention methods. This is an outstanding opportunity to be part of a company that is crafting the future of AI and computing.

What youll be doing:

Own Product Quality and Reliability performance of Networking system products. Providing leadership expertise in product performance and quality.

Maintain and monitor product health thru structured routines and metrics, enable effective alert mechanism for early identification.

Lead structured problem solving and risk assessment for quality issues originating from production and customer. Ensure product readiness for HVM manufacturing and scale.

Responsible for customer quality issues and working within organization to resolve.

Lead critical processes for product performance e.g - CRB, PCN ; Non conforming material review - MRB.

Drive continues improvement initiatives in design, verification and validation processes, manufacturing quality throughout the entire product life cycle and improvement plan.

Are you ready to power the future? we're a global leader in smart energy technology, with over 3,000 employees, offices in 34 countries, and millions of installations worldwide. Our innovative solutions include solar inverters, battery Storage, backup systems, EV charging, and AI-based energy management. We're committed to making clean, green energy the primary power source for homes, businesses, and beyond. With the growing demand for electricity, the need for smart, clean energy sources is constantly rising. we offers amazing opportunities to develop your skills in a multidisciplinary environment, covering everything from research and development to production and customer supply. Work with talented colleagues, tackle exciting challenges, and help create a sustainable future in an industry that's always evolving and innovating. Join us and be part of a company that values creativity, agility, and impactful work is seeking a Quality Director for Sella1 production site located at Tziporit industrial zone Nof Hagalil. This is a high-level executive position with broad responsibility for product quality, and adherence to strict professional and regulatory standards. The role is suitable for a candidate with significant management experience, capable of leading complex domains, implementing processes, and establishing long-term quality infrastructures. Key Responsibilities: Overall Leadership: Full responsibility for Production site Quality, Failure analysis investigation with solid relationship with production site and HQ technical and Q&R owners.. Strategy & Execution: Formulating and implementing Quality strategies aligned with operational and business goals. Compliance & Regulation: Leading quality systems and standards (ISO), ensuring compliance with regulatory requirements, and managing internal and external audits. Continuous Improvement: Leading and managing corrective actions and process improvements plans and processes. Performance Management: Setting goals, KPIs, and monitoring the performance of productions and Quality units. Supply Chain Quality: Overseeing supplier quality control processes. NPI (New Product Introduction): Leading quality control in the onboarding of new products. Representation: Representing the production site before regulators, customers, audit bodies, and business partners. Mentorship: Professional leadership and coaching of Quality and production site teams.
Country:
Israel
City:
Ziporit

We are seeking a Quality Engineer to join our growing operations department. In this role, you will be a champion of excellence, combining a true passion for quality work with a strong discipline for following and improving procedures. You will play a key role in ensuring our products consistently meet the highest standards of reliability and performance, helping us deliver safe, robust, and high-quality solutions to our customers.
Responsibilities:
Serve as a focal point for hardware quality topics with R&D (EE/ME), Operations, Supply Chain, and manufacturing partners.
Monitor production quality performance (yields, defects, scrap, rework) and ensure timely corrective actions in collaboration with R&D / manufacturing partners.
Monitor field quality performance (OOTB experience/RMAs), driving root cause analysis and corrective action implementation for critical hardware issues using structured quality tools (8D, 5 Whys, Pareto, etc.).
Implement, maintain, and improve hardware quality processes across the product lifecycle, ensuring effective adherence to ISO 9001 and relevant hardware/safety standards (CE, EMC, FCC, UL/IEC, WEEE, RoHS, etc.).
Conduct audits at manufacturing lines and CM sites and represent the company in front of customers and certification bodies' audits.

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.

we are a global leader in energy-based solutions for Aesthetics and Eye Care. With more than 1000 employees worldwide and sales in over 100 countries, we are headquartered in Yokneam and have offices in Tel-Aviv.
We are looking for a Supplier & Operations Quality Engineer for the QA team, Youll Cover all quality aspects related to production, Process control and improvement, data collection and analysis. Quality investigations and training/qualification session to production at sub-contractors, Support QA transfer to production from development stages, Support QA transfer of production sites (TK & FTK).
Main Duties:
Supporting all quality activities in products, quality events investigation in production line at sub-contractors.
Ensure the quality of deliverable parts/materials and services by the suppliers.
Data collection and analysis - periodic reports and trend analysis (MRB, Complaints, Yield).
Perform Incoming inspections for materials / products that arrived in our company as part of verification of purchased products.
Product final release activities include DHR review for systems and accessories.
Review of & approve e-DHR conversion activities with FTK sub-contractors including validation final approval.
Quality meetings lead, preparation and summary distribution per line of products (platform), Quarterly quality Reports, QBRs and presentations.
Lead quality process improvement.
Supporting non-conforming material control and MRB.
Complaint trending per platform on a quarterly basis - Field complaint investigations.
pFMEAs establish/update per product and maintenance at least once a year.
QA Plan and report preparation and execution.
FAI for new parts & projects related to engineering changes (Cost reduction, production transfer etc.).
Execution of process and test method validation activities for transferred and updated manufacturing processes and sites.
Supplier Audits and certification.
Supplier corrective action request (SCAR) initiation and follow-up.
Quality related training for production employees.
QA SOPs & WIs update.
Systems refurbishing committees at subcontractors.
Supporting internal CAPA processes and actions.