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Human Xtensions is an Israeli public company developing technology in the field of Minimally Invasive Surgery. We are seeking a talented Design Control Manager to join our QA team.
The Design Control 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.
Responsibilities
- 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.
Requirements
- Bachelor’s degree.
- Previous experience in QA or V&V roles.
- At least 3+ years of experience in the medical device industry.
- Excellent understanding of quality management systems and their application in design.
- Strong knowledge of design control regulations and standards (e.g., FDA, ISO 13485) – an advantage.
- Experienced with IEC60601, IEC6101001 and IEC 62304.
- Experience with internal and external design control and quality assurance audits.
- 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.
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