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Human Xtensions is an Israeli public company developing technology in the field of Minimally Invasive Surgery. We are looking for an experienced Design Quality Assurance Engineer to join our QA team.
The Design QA Engineer will be responsible for designing, developing, and managing new products under development. Also, the QA will conduct internal and external audits, manage CAPA activities, monitor KPIs, and assist in a complaint investigation.
Responsibilities
- Lead the design control process, ensuring compliance with applicable regulations and standards.
- Act as a design QA in all R&D projects.
- Lead DFMEA activities, conduct risk assessments, and facilitate risk management activities throughout the design process.
- Management DHFs.
- Review and approve deliverables and additional documents required for the R&D projects.
- Develop and implement effective quality systems and procedures related to design control.
- Conduct internal and external audits to assess compliance with regulations and company policies.
- Manage CAPA activities, including identifying root causes, implementing corrective actions, and verifying their effectiveness.
- Monitor KPIs to assess the quality system’s effectiveness and identify improvement areas.
- Assist in investigating complaints, including gathering data, conducting root cause analysis, and developing corrective actions.
- Communicate quality issues and recommendations to the QA team and other stakeholders.
- Stay up to date with regulations and industry trends related to quality assurance in the medical device industry.
- Works closely with R&D and other cross-functional teams to design requirements and identify and mitigate quality risks to support new product development projects.
Requirements
- Bachelor’s degree.
- 3-5 years of experience in quality assurance in the medical device industry.
- Multidisciplinary (mechanics, HW, SW) medical device experience – an advantage.
- Knowledge of FDA regulations, ISO standards, and other relevant quality standards.
- Experienced with IEC60601, IEC6101001 and IEC 62304.
- Experience in conducting audits and managing CAPA activities.
- Strong analytical and problem-solving
- Critical thinker, proactive approach, highly motivated and accountable.
- Proficient use of standard MS Office applications.
- Fluent in English (oral and written).
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