T
terry31575
I am at a small device start-up. We are working towards being ISO 13485 and 21 CFR 820 compliant.
I am the quality manager and I have one document control person working for me. I am in the process of hiring a QC person as move into manufacturing. I do not have a specific QA person.
Does anyone see a problem with the Quality Manager acting as QA and being the direct supervisor of QC? I can see how this would be a conflict of interest but we are also small company and can only hire so many employees. Is there a guidance or regulation around this?
Thanks
Terry
I am the quality manager and I have one document control person working for me. I am in the process of hiring a QC person as move into manufacturing. I do not have a specific QA person.
Does anyone see a problem with the Quality Manager acting as QA and being the direct supervisor of QC? I can see how this would be a conflict of interest but we are also small company and can only hire so many employees. Is there a guidance or regulation around this?
Thanks
Terry