QMS Engineer

We are seeking a detail-oriented and experienced QMS Engineer with a background in the medical device industry to join our team. As a QMS Engineer, you will play a crucial role in establishing, implementing, and maintaining our organization’s Quality Management System in compliance with relevant regulations and standards. If you have a strong understanding of quality management principles, experience in developing and improving QMS processes, and a passion for ensuring product quality and regulatory compliance, we invite you to apply for this position.

Responsibilities:

• Ensure that all processes within the QMS are properly defined, documented, and up-to-date to reflect changes in regulations or organizational needs.
• Collaborate with cross-functional teams, to establish and document procedures and work instructions.
• Stay up-to-date with applicable medical device regulations, standards, and industry best practices, such as FDA regulations.
• Coordinate CAPA process, conduct an investigation using quality tools, and lead CAPA plans.
• Implement quality plans within the company 
• Coording management review, and follow up on KPIs. Analyze data and trends specific to the regulation and standards to identify opportunities for improvement and implement corrective actions as necessary.  
• Maintain a robust document control system to manage quality-related documents.
• Coordinate and support internal and external audits. Prepare and facilitate audits, ensuring compliance with relevant standards and regulatory requirements.
• Develop and deliver training programs to enhance awareness and understanding of the QMS throughout the organization. Collaborate with the training department to ensure the training and qualification of personnel involved in quality-related activities.
• Provide guidance and support to employees on QMS-related issues.
• Collaborate with cross-functional teams to identify and assess risks associated with QMS  and regulatory compliance 

Qualifications:

• At least 5 years of experience as a QMS Specialist/Eng./Manager
• Bachelor’s degree in a relevant field, such as Engineering, Computer science, etc.
• Strong knowledge of quality management principles specific to the medical device industry, including ISO 13485:2016, FDA QSR, and EU MDR (an advantage) experience with Multidisciplinary products or SaMD (an advantage).
• Familiar with cybersecurity and privacy standards and regulations, such as ISO 27001:2013 – an advantage
• Experience working in a software company, with a dynamic environment
• Certified Quality Engineer (CQE / CQM) – an advantage
• Certified Internal Auditor – an advantage
• Proven track record of communicating effectively in English, both orally and written.
• Previous experience in implementing and maintaining a QMS in the medical device industry, with a solid understanding of medical device regulations and standards.
• Familiarity with applicable regulatory requirements and standards, such as ISO 14971 and IEC 62304.
• Strong analytical and problem-solving skills
• Attention to detail and a commitment to maintaining high-quality standards
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

** Our office is located in downtown Haifa, a walking distance from the train station, and we’re working hybrid!