we aim to improve patient outcomes by empowering every gastroenterologist across the globe with artificial intelligence and disruptive therapeutic technologies.
In this exciting role as an Operation Quality Engineer, you will directly support the day-to-day Yokneam products manufacturing, transfer, and improvements activities. You will have the opportunity to drive a culture of continuous improvement by deploying sound engineering fundamentals to achieve quality objectives and ultimately yielding better patient outcomes.
A Day in the Life
Communicate quality standards and requirements within the organization and collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
Oversee and participate change approval process (risk assessment, verification, validation).
Lead Quality Assurance and product quality improvements in cross-functional initiatives. Ensure that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
Collaborate with global Operations, QA, Engineering and Manufacturing to ensure quality standards are in place and support day-to-day manufacturing activities.
Specialize in the areas of production control, incoming material, product evaluation, and reliability, inventory control, and development as they apply to product or process quality.
Take an active role in leading and reviewing design and manufacturing changes and lead product quality investigations in support of CAPA, complaints and non-conforming material processes and lead Quality Assurance and product quality improvements in cross-functional initiatives.
Requirements: Bachelor degree in mechanical, industrial or similar engineering disciplines.
3+ Years of Quality Assurance experience in Medical device companies or other highly regulated industries.
Strong written and verbal communication skills (English and Hebrew)
Strong knowledge of applicable standards and regulations standards (FDA, ISO13485, MDD).
Auditing experience.
Nice to Haves
Strong understanding of process validation principles, including experience with master validation plans, installation qualifications, operational qualifications, process qualifications, and test method validations.
Vast experience with design changes, change impact assessment and design transfer activities.
Certified Quality Engineer (CQE) or other similar Quality/reilibility certifications.
Six Sigma certification.
This position is open to all candidates.
