The company, with offices in Israel, USA, Japan, and the Netherlands, is a dynamic medical device start-up committed to advancing digital health innovations for the betterment of patients worldwide. Leveraging artificial intelligence (AI) and computational science, the company’s flagship system combines cutting-edge technology to provide medical professionals with comprehensive physiological insights, empowering them to enhance treatment choices for patients dealing with coronary artery disease.

In a recent development, the company has entered a strategic alliance with Medtronic to globally promote and distribute the flagship system. Medtronic stands as a worldwide leader in medical technology, boasting a presence in over 150 countries with a workforce exceeding 90,000 employees. This partnership is set to expand the company’s global reach, ensuring that its groundbreaking technology, poised to revolutionize the current coronary physiology landscape, reaches and benefits a larger number of patients.

As a QA Engineer within the company, you will assume responsibility for evaluating regulatory implications of software design modifications and ensuring adherence to pertinent regulatory authority requirements. You will function within a dynamic start-up setting that fosters inspiration, encourages challenges, and provides unwavering support for continuous professional growth within a collaborative team ethos. If you possess an entrepreneurial spirit and have demonstrated your ability to collaborate with diverse stakeholders within an innovative environment, the company presents an ideal opportunity. This role reports directly to the Vice President of Quality & Regulatory.

Role Description & Duties:

• Oversee global Customer Complaints handling – spearhead the complaint resolution process, offer technical investigation support to R&D units, document investigation findings and the underlying causes of failures.
• Lead QA assistance for software updates and releases – evaluate the quality impact of new functionalities, lead and document risk evaluations, scrutinize R&D testing documentation and user manuals.
• Administer Engineering Change Orders (ECO) – initiate and oversee software change orders.
• Manage CAPAs and SCARs – instigate and oversee Corrective and Preventive Actions (CAPAs) and Supplier Corrective Action Requests (SCARs).
• Maintain and revise the Approved Supplier List.
• Act as the administrator for the eQMS Document Control software, collaborating in the establishment of new eQMS procedures on a global scale.
• Take part in regulatory assessments and audits conducted by third parties.
• Provide support for Quality Management System (QMS) projects and regulatory submissions.

Necessary Qualifications/Skills:

• B.A or B.Sc. degree in a pertinent field.
• Minimum of five (5) years of experience in Quality Assurance & Regulatory Affairs within the medical device sector, with a preference for experience in CAPAs / ECOs / Complaints handling procedures.
• Familiarity with ISO13485, GDP, FDA QSR, and EU MDR requirements.
• Experience in the realm of medical device software (IEC62304, SDLC) is advantageous.
• Proficient in written and verbal communication in both Hebrew and English.
• Aptitude for coordinating/participating in multiple tasks and projects within a fast-paced environment, demonstrating organizational prowess and meeting deadlines.
• Skillset encompassing self-motivation, a driven disposition, effective communication and interpersonal abilities, attention to detail, and adept time management.
• Comfortable engaging in global communications spanning diverse cultures and time zones.