Rapid Medical, located in Yokneam, is a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. We are looking for a talented QA Engineer to join our Quality and Regulatory department.
SCOPE & RESPONSIBILITIES • Manage suppliers and oversee supplier management activities. • Conduct regular quality control audits to ensure vendors comply with company standards. • Manage DCOs and ECOs. • Take responsibility for MRB management, including trend analysis. • Perform incoming inspections. • Manage NCR and CAPA processes. • Review and approve DHRs for batch release, labels, and route cards. • Participate in internal and external audits, such as FDA inspections and notified body audits based on ISO13485, EUMDR, and MDSAP. • Write and update QA procedures to ensure compliance with quality standards and regulatory requirements.
B.Sc. in Science/Engineering. • 2-5 years of experience in medical device QA (ISO 13485, FDA QSR 820), particularly in supplier management - essential. • Strong attention to detail. • Internal auditor certification. • Proficient in English (both written and spoken) - essential. • Ability to interpret instructions in various formats (written, oral, diagram, or table form). • Problem-solving skills – problems defining, data collection, fact analysis, and drawing valid conclusions. • Knowledge of LEAN methodology or equivalent - preferred. • Self-learning ability. • Excellent teamwork and customer service orientation. • Full control of all MS-Office applications, knowledge in Minitab – preferred .