QA&RA Director

HumanTouch Surgical (continuing Human Xtensions) is a cutting-edge start-up developing multi-disciplinary products in the field of Minimally Invasive Surgery.

·      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.

Requirements

·      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 English (oral and written).