QMS Engineer

Requirements:
At least 5 years of experience as a QMS Specialist/Eng./Manager
Bachelors 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.