QA/RA Assistant

Noris Medical is looking for a QA/RA assistant to join our global QA/RA team!

·  Regulatory support and initial registration administration of the company products in different countries.

·  Administration of translations, notary, apostille, etc. of Regulatory documents.

·  Update to Technical File.

Authorities:

      ·   Routine administration of all above-indicated areas.

      ·   Approval and control of company quality status using an internal audit system.

Experience Required:

·    Proven work of at least 2 years of experience as a Quality Assurance Assistant or similar role

·    Working knowledge of tools, methods, and concepts of quality assurance

·    Solid knowledge of relevant regulatory standards-advantage ISO 13484

·    Good communication skills, both verbal and written

·    Excellent data collection and analysis skills

·    Strong attention to detail

·    Relevant training and/or certifications as a Quality Assurance Assistant

·    Risk Associated with the job (e.g. possible effect on product safety, performance, etc.)

·    Failure to execute the job as required may affect product quality or specification but does not put the user/patient at risk 

·    Risk type- B

Applicable QA procedures:

      ·   All QA Procedures, and other quality-related documents – specifications, QC documents, working instructions, etc.

      ·   See training matrix QAF 6205

Required Training: Self-reading of all indicated documents.

Required Qualification: Training and qualification will be provided by the Company.

Effectiveness check type

·    Internal/External audit 

·    Review of documentation