May 202519training, corrective action management, non-conforming product management, environmental controls, and complaint management. Some titles include doc control clerks, calibration tech, and quality systems engineer.Quality Engineering BranchEnsures all engineering efforts of quality are maintained and effective. Some examples of what would be managed within this branch are engineering change support, maintaining PFMEAs and control plans, supplier change support, project support, scrap reduction efforts, investigations of non-conforming products, and complaint investigations. Some titles include quality engineer, supplier quality engineer, and quality technician.Quality Control BranchEnsures your production floor is supported and controlled. This is your direct group that supports the device itself coming off the production line. Some examples of what would be managed within this branch are inspections of devices, compliance with clean room requirements, release of product that is ready to ship, and labeling of devices. Some titles include quality control inspector, incoming/receiving inspectors, quality control lead, and quality control supervisor.With the branches defined, you can assemble your job descriptions and org chart accordingly. Depending on the size of the organization, there can be a leader to each branch to allow layers within your org chart. These layers will allow heightened focus on each branch. It gives each branch a focal point with a structured view. This allows each branch/leader to not be so overwhelmed with the entire QMS. They have their own contribution to maintain, and they can also work cross-functionally where necessary to ensure the efficiency of the QMS. I have recently taken on two divisions at my company as the divisional director of quality. These divisions have essentially the same QMS but require different structuring of the branches based on the size. One division is half the size in headcount than the other; there are also some fundamental differences as one has a larger R&D and transfer project base, and the other has a larger manufacturing platform. As all those differences are considered, you can successfully bucket the groups accordingly. There may be exceptions depending on employees, skills, customer needs, etc. Nothing has to be concrete; just give every decision some good thought and structure consideration behind it, and you can adjust accordingly where needed. Below is an example of how to branch the org chart to cover your branches and systems properly. Having an effective quality management system (QMS) is required for any medical device company
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