לוח משרות דרושים ייצור ותעשייה ביקנעם עילית

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.

Main Duties & Responsibilities
Initiate, manage, and track PLM processes like Change Orders (COs) throughout the product lifecycle.
Lead design transfer activities from R&D to production, ensuring smooth and robust transition to manufacturing.
Support production lines during ramp-up and ongoing manufacturing, including yield improvement and process optimization.
Manage the interface with subcontractors and external suppliers, including technical oversight and issue resolution.
Serve as the engineering focal point for the Business Unit, Production, Quality, and other internal stakeholders for all engineering-related activities within the assigned platform.
Participate in cross-functional problem-solving teams to resolve production, quality, and design issues
Optimize PLC management process and tasks using AI tools
Assist the system Engineer with root cause analysis (RCA) activities and drive corrective and preventive actions (CAPA).
Provide Design for Manufacturing (DFM) and Design for Assembly (DFA) inputs during the design and development phases - Nice To have.

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.

A growing start-up company is seeking an experienced Customer Operations Expert to lead the deployments projects, coordinate between customers, partners, and internal teams, and ensure smooth end-to-end implementation using internal tools.
Work Model -Hybrid: 3 days per week onsite in Yokneam Ilit, 2 days working from home.

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.

This role at our company Yokneam is responsible for designing, optimizing, and sustaining manufacturing processes in a highly regulated medical device environment. The position partners closely with Production, Quality, and R&D to drive operational excellence, implement MPS methodologies, and improve key operational KPIs such as yield, quality, and OEE, while ensuring full compliance throughout the product lifecycle.
Responsibilities may include the following and other duties may be assigned:
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensures processes and procedures are in compliance with regulations.
Monitors documentation maintenance throughout all phases of product lifecycle.
Drives a continuous improvement mindset by engraining and improving the MPS (our company Performance System) methodologies in the day-to-day.
Main contact with Operations Innovation and region improvement team.
Execute Improvement in Yokneam Operations KPIs (Yields, Quality, OEE).
Acts as a partner with mainly production and Quality operations and other functions in Operations and R&D sustain team.

In this role you will be responsible to managed SCRs (Suppliers Change Requests). You will report to Supplier Quality manager. Come strengthen your specialized skills and enhance your expertise. Well support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way thats best for you.
Responsibilities may include the following and other duties may be assigned:
Complete Supplier Change Control activities on time to prevent any line disruptions.
Understand and operate according to medical device regulatory guidelines (GMP, FDA, ISO13485, AIMD R-PAL) and company Quality System procedures.
Measures performance against process requirements.
Coordinate and follow up with different internal functions to ensure an on-time execution.
Communicates team progress.
Required Knowledge and Experience:
3rd or 4th year of Industrial Engineering/Quality Assurance or equivalent degree study
Proficient in English.
Good inter-personal skills - motivate without authority.
Meticulous with close attention to details.
Capabilities and desire for self-learning.
Experience in a Medical device company or Quality Assurance.

At our company Yokneam, we are driving innovation in gastrointestinal diagnostics, transforming patient care with minimally invasive solutions. Our multidisciplinary teams in R&D, engineering, manufacturing, and quality work together to develop, produce, and deliver cutting-edge medical devices that improve patient outcomes worldwide. We are seeking a Manufacturing Engineering Manager to lead engineering initiatives, optimize production processes, and ensure high-quality, efficient manufacturing of our next-generation GI diagnostic technologies. This role offers the opportunity to make a significant impact on global healthcare while working in a collaborative, innovative environment.
Responsibilities may include the following and other duties may be assigned:
Plans, directs, and implements all aspects of the company's site engineering activities (safety, manufacturing process performance, testers development and implementations, product configuration, PMO, validation aspects, etc).
Develop, evaluate, implement, and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
Oversees the investigation and evaluation of existing technologies, testers development and implementation in production process.
Monitors documentation maintenance throughout all phases of product lifecycle.
Selects, develops, and evaluates personnel to ensure the efficient operation of the function, driving performance and increasing people engagement.
Drives a continuous improvement mindset in Engineering by engraining and improving the MPS (our company Performance System) methodologies in the day-to-day.
Has budget accountability for the department including CAPEX investment plan.
Meets deadlines on critical projects & Actions committed by Site Eng Org (CAPA / PMO Projects / EHS / Local Projects)
Ensures that quality tools such as CAPA / FMEA are understood and used by Site Eng department
Improves Yokneam Operations KPIs (Yields, OEE, Savings).
Improves manufacturing availability means (OEE, up-time, Productivity)
Controls and improve process and product performance (RTY, Scrap reduction)
Reduces cost and improve productivity (Costs, Programmatic Savings)
Leads and coordinates product quality investigations. Acts as a key partner on investigating root causes