GE HealthCare Quality Engineer 

Israel 

940059948

The Quality Assurance Engineer is responsible for providing guidance for engineering process support in accordance with documented procedures and practices.
In addition, the QE will need to develop and maintain systems, procedures, and processes to ensure fulfillment of internal and external requirements based on medical device standard ISO 13485. Ensures compliance to applicable standards and regulations. Has knowledge of best practices including vast knowledge in design & development methodologies.

Roles and Responsibilities

As part of your role, you will:

• Ensure the product is developed per a well-defined Design Controls process and procedure, from planning, to design and implementation, verification and validation, and finally design transfer to manufacturing. Make sure everything is documented, risks are mitigated, and traceability is established end-to-end
• Support product development at all project phases, ensure development and design reviews (FDRs, TDRs, etc.)
• Support requirements initiation / rationales for requirements and testing (e.g., testing covers all requirements, and applicable configuration)
• Manage DHF activities and documentation, initiate, and review program deliverables and ensure that the deliverables are in compliance with company’s QMS, applicable standards and regulations
• Handle and coordinate Risk Management activities (experience with ISO 14971 preferred)
• Handle QMS activities at the site including quality trainings, internal audits, quality management reviews and implementation process of global procedures
• Take a leading role in external audits and internal audits
• Interfaces with R&D, Regulatory Affairs, Clinical, Process Development and Manufacturing functions in a project team environment

• Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
• Acts as a resource for colleagues with less experience. May lead local improvement projects and be part of global GE projects/initiatives. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
• Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
• Uses judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.

Requirements

• B.Sc in Mechanical / Biomedical / or similar from a known academic institution.
• 3-5years of hands-on experience in a similar role in a multi-disciplinary medical device company (Hardware, Software, Mechanics), working according to the MDR and CFR 21 Part 820, ISO 13485 regulatory requirements, ISO 14971, IEC 62304, IEC 60601
• R&D experience in a multi-disciplinary company – advantage
• Demonstrate in depth experience and understanding of product development lifecycle and design control activities (including Risk Management, design input/output, verification and validation etc.) in a medical device environment
• Experience with cross functional project teamwork and collaboration with R&D, RA, QA, Product, Program, and Operations team members
• Strong interpersonal, written, and verbal communication skills (Hebrew & English)
• 3-5years working experience in Quality Engineering in Medical Device company.

• Strong oral and written communication skills. Demonstrated ability to analyze and resolve complex problems. Ability to document, plan and established design documents.
• Demonstrated understanding of product development lifecycles, design changes and document change control, process verification and validation methodologies, design transfer, and servicing in a medical device environment.

• Ability to multi-task&handle tasks with competing priorities effectively
• Excellent interpersonal relationship – team player and team -oriented.
• Demonstrated collaboration, negotiation&conflict resolution skills.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies&in-depth understanding of site level products&related processes

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.