Augma Biomaterials is a Medical Device company that develops, manufactures, and distributes dental bone graft materials to countries all over the world.
We are looking for a talented and motivated engineer to join our amazing QA/RA team in Caesarea, Israel.
Job Description
Quality Assurance
– Writing and updating quality procedures, SOPs and WIs – verifying
compliance with regulatory requirements and standards.
– Maintaining the training and qualification of company’s personnel
– Assisting with process and equipment validations (IQ,OQ,PQ)
– Act as a leading QA representative of change controls (ECO) and for
changes related to the QMS.
– Maintain Customer complaints, CAPA, PMS and Non-conforming (MRB) activities.
Regulatory Affairs:
– Prepare and submit FDA and EU submissions for new products and product changes.
– Perform and renew regulatory registrations worldwide (FDA, EU, AMAR, etc.).
– Maintain and manage the technical documentation of company’s products.
– Perform standards review and regulatory gap analysis.
Report to: QA/RA Manager
Education: B.Sc in Engineering in one of the following fields: Quality Bioscience
Position requirements:
– At least 4 years’ experience in QA/RA in a medical device manufacturing
company in accordance with regulatory requirements (FDA QSR 820,
MDR, MDD, ISO 13485 and other markets).
– Experience in submitting medical device registrations/submissions.
– Experience in external regulatory audits (CE/FDA).
– Experience in supporting sterile production and clean rooms – preferred
Language skills: Fluent English – writing and verbal.
Please send CV to: Irena@augmabio.com/ Mor@augmabio.com
Augma Biomaterials is a Medical Device company that develops, manufactures, and distributes dental bone graft materials to countries all over the world.
We are looking for a talented and motivated engineer to join our amazing QA/RA team in Caesarea, Israel.
Job Description
Quality Assurance
– Writing and updating quality procedures, SOPs and WIs – verifying
compliance with regulatory requirements and standards.
– Maintaining the training and qualification of company’s personnel
– Assisting with process and equipment validations (IQ,OQ,PQ)
– Act as a leading QA representative of change controls (ECO) and for
changes related to the QMS.
– Maintain Customer complaints, CAPA, PMS and Non-conforming (MRB) activities.
Regulatory Affairs:
– Prepare and submit FDA and EU submissions for new products and product changes.
– Perform and renew regulatory registrations worldwide (FDA, EU, AMAR, etc.).
– Maintain and manage the technical documentation of company’s products.
– Perform standards review and regulatory gap analysis.
Report to: QA/RA Manager
Education: B.Sc in Engineering in one of the following fields: Quality Bioscience
Position requirements:
– At least 4 years’ experience in QA/RA in a medical device manufacturing
company in accordance with regulatory requirements (FDA QSR 820,
MDR, MDD, ISO 13485 and other markets).
– Experience in submitting medical device registrations/submissions.
– Experience in external regulatory audits (CE/FDA).
– Experience in supporting sterile production and clean rooms – preferred
Language skills: Fluent English – writing and verbal.
Please send CV to: Irena@augmabio.com/ Mor@augmabio.com