Make a Difference for Millions
BNA technology allows medical professionals as well as each and every one of us to better manage our Brain Health.
Solve Complicated Problems
elminda has spent a decade pioneering a fusion of data analytics and brain networks mapping. These quantify function and dysfunction of neurological and psychiatric disorders, outlining the overall condition of our Brain Health.
Be Part of Something Great
Our greatest assets are the people we work with. We are proud to have achieved a work environment that strives together to make something great. We operate in the most challenging arenas – Brain Health and AI. We invest in creating an enriching work environment, driven by talented people who want to share this fascinating path with us!
About The Position
ElMindA, a leading company in the brain health technologies is looking for an experienced and passionate QA/RA Manager. You will join a dynamic and fast-paced environment and work with cross-functional teams to design, build and roll-out products that deliver the company’s vision and strategy.
· Oversee and maintain the company’s Quality Management System QSR/GCP program. Propose and initiate continuous improvement practices
· Implement European regulations ISO 13485:2016
· Conduct and scheduled periodical Quality Management Reviews
· Gather and Analyze product use and failure, customer feedback and complaints, and recommend appropriate changes in product
· Maintenance and implementation of company procedures and quality process, update procedures and verify proper use, functionality and efficiency
· Monitor product development activities and documentation, especially Design Control activities, Design Review meetings, Risk Analysis meetings
· Manage DHF, DMR, ECO/DCO processes and complaints, including expansion of DHF scope
· Management and responsibility of the Corrective and Preventive Action System (CAPA), including investigations and timely completion of corrective actions
· Qualify and Requalify, when appropriate, company Suppliers
· Continuously update, maintain, and oversee the company’s Quality Document Control system
· Train new employees, maintenance of Employee Training Records, and follow company training program.
· Maintain HIPAA/GDPR awareness and training and investigation of HIPAA/GDPR breaches when necessary
· Implementation of digital quality management system
· Management of software and QA consultants
· Manage submissions for additional markets
· Academic education (preferably Biomedical Engineering)
· Proven 4-5 years of employment experience in QA/RA in medical device companies.
· Proven 3 experience with medical software development and certification.
· Hands on experience with ISO 13485, ISO 14971, IEC 62304 etc.
· Languages: Hebrew, English – fluent.
· Accurate, Organized, Multi-tasking and Responsible, positive management attitude and collaboration with different teams.