| Validation Quality Engineer at Remote, Remote, USA |
| Email: [email protected] |
|
From: Shivam Kamboj, Siri InfoSolutions [email protected] Reply to: [email protected] Validation Quality Engineer Jacksonville, FL JD Sr. Software Quality EngineerA minimum of 4 yearsWorking 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 requiredExperience 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. Regards Shivam Kamboj Technical Recruiter Siri Info Solutions. Mail Id: [email protected] Keywords: Florida Idaho Validation Quality Engineer [email protected] |
| [email protected] View All |
| 03:33 AM 11-Mar-25 |