דרושים » הנדסה » Manufacturing Operations Quality Engineer R55936

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.

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

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.