עובד.ת איכות, רגולציה וכתיבה טכנית

לחברת GSAP מקבוצת נובולוג דרוש.ה איש.ת QARA בעל.ת רקע טכנולוגי להשתלבות בפרויקטים מאתגרים אצל לקוחותינו בתחום המכשור הרפואי.
התפקיד משלב עבודת איכות ורגולציה קלאסית לצד הבנה הנדסית עמוקה, ומציע הזדמנות מצוינת לביצוע משימות רוחביות במגוון טכנולוגיות מתקדמות וחברות בחזית הרפואה.

QARA Specialist – Medical Device Industry
GSAP is seeking a motivated, service-oriented QARA Specialist with a solid technical background to join our consulting team and support high-profile client projects. This role is ideal for a professional who thrives on bridging the gap between regulatory requirements, quality standards and technical engineering processes.
Scope of work:
QMS Support & Maintenance: Participate in the establishment, daily maintenance, and remediation of Quality Management Systems (including ISO 13485, EU MDR, MDSAP, QMSR, ISO 27001, etc.).
Technical & Regulatory Writing: develop, update, and review technical ation, Work Instructions or Standard Operating Procedures (SOPs), and various product lifecycle records and documentation.
R&D and Engineering Collaboration: Work closely with development engineers and production line teams to draft and align technical and regulatory requirements, v

דרישות:

2-3 years of hands-on QA/RA experience in the medical device industry.
Academic degree (BSc/MSc) in Engineering, Biotechnology, Life Sciences, or a related technical/scientific discipline.
Proven experience or strong aptitude for technical and regulatory writing.
Client-facing communication skills and a service-oriented mindset.
Fluency in English (both written and spoken).
Advantages: Practical experience within R&D, Engineering, or Production Engineering environments, either as a direct member of the departments or as QA engineer or RA person