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Posted: Within 7 days
Hourly Rate: Not Sure   |  Duration: Not Sure  |  Posted: Mar 28, 2015  |  Ends: 2d, 13h  |   3 Proposals
We are medical device company here in San Francisco California, but using a contract manufacturer locally. We need a QA/RA consultant with the following skills and experience to help with our existing QSR and many other projects. We need someone to be able to help us with the following: 1. Serve as the owner/mentor, of key quality system processes: CAPAs, NCRs, Internal Auditing, Complaint Handling, Returned Products, Management Review, Management Responsibility, Risk Management, Design Control, Training, Document Control and Change Control of the Quality System. (including but not limited to 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, MDD 93/42/EEC) including Canadian CE / quality systems. 2. Management Representative responsible for interfacing with Notified Bodies, FDA and State Department of Health during company inspections. 3. Perform statistical evaluation of data pertaining to RMA's, and non-conforming product identified by production and supplier quality in order to ide...
Category: Other Legal Fields       
Skills: FDA, QSR, Quality, Regulatory       

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