Opening for Computer System Validation at Remote, Remote, USA |
Email: [email protected] |
From: Dinesh, kk Associates [email protected] Reply to: [email protected] Hi .. This is Dinesh from kkassociates, Below Position is Immediate Position from the Client Kindly share Suitable resumes to [email protected]. Computer System Validation location: Jacksonville, FL Hire Type: Contract JD; Sr. Software Quality EngineerA minimum of 4 years Working knowledge of FDA and European medical device regulations (QSR and ISO) is required. Working knowledge of software validation requirements for software used in the production of medical devices and software used to support the Quality System is required. Working knowledge of GAMP5 and SDLC is required. Working knowledge of regulations for electronic records, electronic signatures, and data integrity is required Experience with change management and a strength with technical writing is required. Experience with SCADA and/or Manufacturing Execution Systems (MES) and experience working in manufacturing/operations is required. Medical device process validation experience is preferred. Experience in Quality Auditing and notified body inspections is preferred. Experience in Quality Systems process development, support, integration or enhancement is preferred. Experience with training or coaching others is preferred. Software Quality Engineer certification (CSQE) or Quality Engineer certification (CQE) is preferred.A minimum of 4 years of experience in a regulated environment is required Thanks and Regards Dinesh || Technical Recruiter KK Associates LLC. Direct:6143790183 8751 Collin McKinney Pkwy, # 1302, McKinney, TX 75070 555 Metro Place North, Suite# 100, Dublin, OH- 43017 Email: [email protected] Web: www.kksoftwareassociates.com Keywords: Florida Ohio Texas Opening for Computer System Validation [email protected] |
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03:42 AM 07-Mar-25 |