לוח משרות דרושים ייצור ותעשייה במרכז

We are seeking a highly skilled QA and Design Control Manager with proven experience in the medical devices industry to join our team and contribute to the effective maintenance of our (MDR) ISO13485 certified Quality Management System and move us ahead with implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.
Key Responsibilities:
Responsible for managing or governing all QMS-related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Changes, Complaints handling, Recalls, Data analysis, Risk management.
Assuring production line compliance and working closely with the QA at the contracted manufacturer.
Ensuring compliance with in-house procedures through ongoing, periodic audits or inspections.
Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
Guidance by the Design and Development requirements per ISO13485 and Product Realization.
Maintaining design control activities by ISO13485.
Ensuring validation processes are performed and documented.
Provide support for risk analysis processes and technical file maintenance.
Working closely with the Medical Engineering team and R&D team
Making the quality world accessible to the Engineering and R&D team
Reports directly to the VP of Regulatory Affairs & QA

We are looking for an R&D Technician to join our top-talented multidisciplinary R&D team. The ideal candidate should be striving for the challenge of making a significant impact in a multi-disciplinary product in the med-tech industry; hands-on and highly technical.
The R&D Technician will provide diagnosis and analysis of all development aspects including solving technical problems.
Key Responsibilities:
Perform tests and Research (using JIGs, Apps, and specially designed tools).
Conducting electro-mechanical experiments for research, development, and validation.
Perform routine chemistry laboratory duties, such as weighing, and evaporating.
Working closely with the test and development teams.
Reading and writing reports related to R&D or testing.

Power the Future with us! We are a global leader in high-performance smart energy technology, with over 5000 employees, offices in 34 countries, and millions of products installed in over 133 countries. Our diverse product offering comprises intelligent solar inverters, battery Storage, backup systems, EV charging, and complete home energy management ecosystems. By leveraging world-class engineering capabilities and with a relentless focus on innovation, we strive to create a world where clean, green energy from the sun is the primary source of power for our homes, businesses, and just about everywhere we thrive
As a safety officer you will be part of the global EHS team.
What will you be doing:
* Write health and safety programs on the sites that are under your responsibility.
* Write emergency plans in accordance with the nature of the activities in the different divisions and conduct the yearly emergency drills plan. Perform risk surveys in the activities under review and report to management about the risks found.
* Perform periodic hazards identification surveys, report to management about the findings and non-conformities, and handle the process of hazards elimination.
* Lead safety committees, including the preparation of the presentation of the content.
* Make sure that the approved Safety Management Program is appropriately implemented and met.
* Ensure that the safety equipment and tools are in order and appropriate to the activities in the respective division.
* Coordinate and validate with external contractors and franchisees that a relevant safety plan is approved and its requirements are met.
* Write and update health and safety procedures and work instructions
* Train and supervise health and safety training
* Sample periodically that contractors and other partners are appropriately trained.
* Perform investigations of safety accidents and incidents, including identifying root causes, issuing recommendations for improvements, and writing a summary report.
* Summarize the incidents, accident data, and characteristics to learn and implement improvement plans.
* Recommend health and safety improvement plans in the different divisions.
* Perform any other duty that you will be instructed to do by the management related to health and safety.
Country:
Israel
City:
Modiin