Human Xtensions is an Israeli public company developing technology in the field of Minimally Invasive Surgery. We are seeking a talented Quality Assurance Manager to join our QA team.
The QA Manager will play a critical role in establishing and maintaining the design control activities and act as the focal point for quality assurance within the R&D department. Also, you will be responsible for regulatory support and customer complaint handling and partner with R&D, Operations, and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.
- Develop and execute quality design (design control) and quality assurance strategy for new product development and sustaining business activities.
- Lead all R&D projects from the design QA side through the design phases.
- Ensuring compliance with DHR and DMR requirements
- Developing and managing risk mitigation strategies for the project together with R&D.
- Support regulatory submissions.
- Plan, establish and maintain the effectiveness of company quality to meet regulatory expectations.
- Accountable for the company’s product quality and reliability to meet or exceed customer expectations.
- Liable for the company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards worldwide.
- In support of the quality system, provide effective leadership support, training, and guidance to all company personnel.
- Write or guide employees in writing all company procedures, specifications, instructions, etc.
- Maintenance of the QA system.
- Periodic reports to Top management about Quality issues and analysis of MRB, CAPA, ECOs, internal and external audits, and product and process performance.
- Leading MRB, CAPA, and ECO committees.
- Responsible for internal audits system.
- Subcontractors’ approval, audits, and control over their performances.
- Establishment and control of traceability system of company product (DMR).
- Responsible for approval of finished product release.
- Bachelor’s degree.
- At least 5+ years of experience in the medical device industry.
- Multidisciplinary (mechanics, HW, SW) medical device experience – an advantage.
- Strong knowledge of design control regulations and standards (e.g., FDA, ISO 13485).
- Experienced with IEC60601, IEC6101001 and IEC 62304.
- Demonstrated expertise in leading design control activities, including risk management, verification/validation, and documentation.
- Excellent understanding of quality management systems and their application in the design process.
- Experience with internal and external audits related to design control and quality assurance.
- Strong analytical and problem-solving skills, with keen attention to detail. Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
- Proficient use of standard MS Office applications.
- Fluent in English (oral and written).