Quality Management System Officer – TLV

Job Description:
Responsible for implementation and maintenance of the Quality Management System (SOP’s) to adhere to company’s internal Quality Management System and relevant Regulatory bodies.
Ensures processes, tools and any other relevant activities are consistently compliant with relevant regulatory requirements.
Build and manage design and processes for development and operational activities.
Experience in validation activities.
Act as the internal singular focal point for all validation activities throughout the design, development and maintenance of the systems.
Requirements:
• At least 3+ years (or equivalent combination of education and related work experience) of medical device/pharma industry experience with relevant regulatory and quality standards.
• Exceptional interpersonal, written, and oral communications skills.
• Experience with quality standards.
• Ability to function efficiently and independently in a fast-paced, changing environment.
• Ability to prioritize and recognize the most important aspects of a development process.
• Self-motivated and willing to accept volatility in a work environment.
• Working knowledge and experience in quality processes.
• Ability to write, proofread, and check documents for accuracy; ability to relate information to requirements and the ability to identify inconsistencies.
• Excellent communication, organizational and problem-solving skills.
• English level – high
• Team player
Preferred experience and education – advantage:
• BA in Engineering, Regulatory Affairs or related field.
• 3+ years (or equivalent combination of education and related work experience) in new device regulated product strategy and submissions; including working knowledge of U.S. laws and FDA regulations as well as CE and international laws and regulations, and guidance applicable to registration, approval and maintenance of health-related platforms and technologies.
• Working knowledge of an Agile/Scrum environment.