QA & RA Specialist

Company Description

Novoxel® is a medical device company that has developed Tixel®, a novel thermal technology for fractional skin resurfacing. Tixel® employs TMA® technology which uses a matrix of tiny pyramid-shaped pins made of biocompatible materials to transfer thermal energy to the skin.

The company is based in Netanya. 

Roles and Responsibilities

• Management and control of the quality assurance processes
• Product quality maintenance
• Control and monitoring of production, QC and engineering processes
• Compliance with MDR 2017/745/EU, ISO 13485 and USA 21 CFR part 820
• Production support
• Responsibility for quality systems and document control per regulatory requirements and internal SOPs
• Response to customer complaints
• Creation and maintenance of all quality documentation
• Responsibility for job descriptions, training programs and certifications of Novoxel employees
• NC and MRB process oversight
• CAPA initiation and execution
• Change control process management
• Supplier management, including supplier approval process, supplier audits, MRB and SCARS
• Support of regulatory submissions
• Product life cycle regulatory reports

Requirements:

•  B.Sc. in Life Science disciplines or Engineering
• At least 5 years of experience within a similar role in the medical devices industry
• Deep understanding of the EU and USA medical device regulations, including MDR 2017/745/EU, FDA 21 CFR Part 820 and ISO 13485 requirements
• Excellent problem-solving skills
• Excellent written and verbal communication skills
•  Strong organizational skills
• Ability to work independently