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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

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.