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hruship101 replied to the topic PM: Quality Assurance Process in the forum Project Management Process and Medical Device Development 8 years, 1 month ago
I agree with all the participants in the posts above regarding the role of PM and his or her duties of Quality Assurance. Quality Assurance responsibility is a huge task within Quality in a medical device industry. Few tasks that I will be responsible in terms of input are to make sure to obtain complete details of the manufacturing process before finalizing the deadline. Furthermore, I would have to meet with the subject matter expert (SME) to make sure research has been done completely on the project. Moreover, in terms of output, I would need to make sure all the correct documentation has been done and signed off by the appropriate manager. In the medical industry, documentation is more important and is required by the FDA to maintain record of production.