We are looking for an experienced RAQA Engineer to join our RAQA team at InspireMD, a dynamic medical device company that specializes in design, manufacture and marketing of stent implant systems.

Your role will be to support maintenance and improvement of the quality management system, support of design control activities, internal audits, supplier audits, participation in external regulatory audits, support in preparation of regulatory submissions for the company products, participation in risk management activities and more.

Essential Duties and Responsibilities

• Support the quality management system to meet all relevant regulatory requirements of ISO 13485, MDR 2017/745, FDA 21 CFR Part 820, and other applicable medical device regulations and standards.
• Handle and support processes of change orders, corrective and preventive actions, non-conforming product, complaint handling, calibrations
• Responsible for document and record control in eQMS
• Perform internal audits
• Supplier management including conduct of supplier audits, approval of suppliers, annual supplier evaluation and routine contact with suppliers.
• Support product and process V&V activities
• Support design control process for R&D projects
• Participate in risk management activities
• Prepare documentation for new products regulatory submissions and changes to existing products
• Initiate and update company procedures and work instructions
• Gather data for trend analysis and quality objective KPI’s for Management Review
• Maintain device product files (DMR, DHF)
• Handling and maintenance of Employee training
• Perform gap assessments of regulatory standards
• Perform product release QA activities before shipment
• Participate and prepare for external audits by Notified Body, FDA and other regulatory authorities.
• Interface with all departments in the company to provide QARA assistance, guidance and support

Requirements (Relevant Education/ Languages, Skills)

• Bachelor’s degree in a relevant scientific or engineering field.
• Minimum of 5 years experience in RA/QA in a medical device company
• Experience in medical device manufacturing processes and clean rooms according to FDA 21 CFR Part 820, ISO 13485, and relevant industry standards
• Experience with Class III implants – advantage
• Experience in medical device manufacturing and post-market activities for the EU and US market – advantage
• Lead Auditor certificate from a recognized institution – advantage
• Strong analytical, problem-solving, and communication skills.
• Attention to detail and a commitment to quality.
• Ability to work independently
• Ability to work under pressure to meet company goals and deadlines
• Team player
• English – high level – both written and verbal