Israel
#Quality Manager #Digital Health # Computerized Systems SDLC #Healthcare Software Quality Consulting Over 25 years of multidisciplinary experience in the areas of Digital Health, Healthcare Quality and compliance, Software and Biotech development and software testing. Having hands on experience as a Healthcare Industry Engineer, Software Developer and Tester, allows me to provide efficient and focused compliance solutions based on deep understanding of the technical matter and the compliance requirements.
Manage over 80 employees including ongoing hands on expertise in the following areas: Computerized systems SDLC: Computerized systems validation projects (e.g. : ERP, laboratory, control systems and more) Creates or updates quality management systems with focus on computerized systems/ software. Experience with 100’s of life cycle projects. Digital Health: Digital health pioneer, lead QA activities for FDA Digital Health approved product (Second approved product of its kind). Provide end to end quality( Pharma\medical device) , quality ( software testing) and compliance solutions. Manage Digital Health teams in the area of: • Quality management : Combination products, medical device. • Verification and validation. • Software manual testing : Front end and backend • Software automation testing. Healthcare software consulting: Consult tier 1 to startup Biotech, Medical devices and Pharma companies in software compliance to FDA and EU standards Audit Biotech\ Pharma\medical Devices companies and their vendors. Prepare customers for regulatory authorities audit in the area of software development life cycle and computerized systems compliance. Standards: ISO 13485, IEC62304, 21CFRPart11, Annex 11, GAMP5,HIPAA
Managed computerized systems validation and global software testing and validation group. Both Designed software requirements and managed testing of in-house development of database applications (File maker- database platform) for clinical trials, manufacturing laboratories and R&D divisions in a pharmaceutical company. Comply with FDA standards for computerized systems -21CFRPart11, Use GAMP4guidelines Designed and implemented the company software QA system – Version control. Bug fixes, system and risk analysis, validation plan, STPs, STDs etc. Implement QA plan to ensure compliance with U.S. Sarbanes-Oxley (SOX) regulations for finance and administrative software. Promoted twice in 18 months based on the ability to handle multiple projects with deep analysis of system requirements and customer needs.
Managed the Medical devices and Biotech software QA division. Designed and implemented SQA systems for client companies ( Bug tracking, version control, project management etc) Provided consulting services for medical devices companies: Software testing, validation and FDA pre-audit QA implementations. Successfully assisted client in passing a critical FDA audit Design and managed group of software testers that perform state of the art validation deliverables like Computer Validation Plan, URS, STP,STD, STR, Disaster recovery, Risk analysis. Responsible for customer relationship management and pre-sale. Awarded as "best employee" in 2 consecutive years based on the ability to complete pioneer projects with high quality and complete customer satisfaction.
Managed software team of 4 programmers in development and maintenance of software based medical system for real-time smart respiratory machine with combined electronic, mechanic and software modules. Code was written in C and C++ Passed successfully ISO 9001 audit and prepared software for FDA audit Stabilized software modules both in software algorithm substance and software group self-testing, working methodologies, software release and software-QA procedures Led change of development concept from "startup procedures" to structured procedures. Identified staff advantages and assigned job accordingly.