דרושים » הנדסה » Production and Suppliers Quality Engineer Leader

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.

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.

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 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 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.

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

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.

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:
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.

we are looking for a QA Engineer.
Job Requirements & Responsibilities
Support and manage core quality activities, including Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), Complaints, and Change Control (ECO).
Assist in the performance and preparation of both internal and external quality audits.
Coordinate and follow up on employee training, qualification, and competency activities to ensure organizational compliance.
Support the qualification and ongoing evaluation of suppliers.
Support the production activities (Review Device History Records (DHRs) and quality documentation for completeness and batch release).
Participation in Design Reviews and verification of execution of Action Items related to quality issues.
Provide quality support for V&V processes, including software validation, equipment validation, and the review of engineering documents.
Administer controlled documents and maintain quality records.