דרושים בתחום מהנדס איכות

· E.S.I Novel ltd’ part of Essence-group, is medical Aesthetics company located in Hertzliya Israeli hi-tech capital. E.S.I Novel design develop & distribute breakthrough innovative state of art professional and home use Medical aesthetics solutions.
· The Company is seeking a Manager of Quality Assurance with experience in the medical device industry and with extensive knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulations (QSRs), International Organization of Standardization (ISO) 13485:2016 Medical Device Directive (MDD) 93/42/EEC, ISO 14971:2007.
· The Quality Assurance Manager will report directly to company General Manager and will work closely within project teams (and in some cases independently) contributing technical leadership/knowledge capabilities.
· This position will contribute to the review of design process, production engineering and production activities. This position will interact with project management, HW and SW teams and other company technical departments and subcontractors on regular bases. R

· Minimum BS/BA in business management or a science discipline (electronic engineering as advantage).
· 5+ years of experience implementing test strategies, process validation and verification in FDA-compliant medical device industry.
· Demonstrated success in a start-up, entrepreneurial work environment.
· Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
· Familiar with EN 60601, Safety requirements for medical electrical systems and ISO 62304, Medical Device Software – Software Life Cycle processes.
· 4 or more years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485 and ISO 14971 standards
· Lead role (administrative or technical) in one or more FDA or other Worldwide medical authority’s submissions for approval of a medical device as advantage.
· Project management skills and proficiency and analysing and interpreting test data.