| Onsite Sr. Validation Engineer, Need European medical device regulations exp at Remote, Remote, USA |
| Email: [email protected] |
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https://shorturl.at/zCvmO https://jobs.nvoids.com/job_details.jsp?id=2311245&uid= From: Shubham Choudhary, Quantum World Technologies [email protected] Reply to: [email protected] Job Title : Sr. Validation Engineer Location : Onsite (Irvine CA/Jacksonville, FL) Interview : Phone/Video Job Description: 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 Unfeigned Regards, Shubham Chaudhary Technical Recruiter [email protected] linkedin.com/in/shubham-choudhary-816b00236 Quantum World Technologies Inc. 4281 Katella Ave, Suite #102 Los Alamitos CA 90720 USA Keywords: California Florida Onsite Sr. Validation Engineer, Need European medical device regulations exp [email protected] https://shorturl.at/zCvmO https://jobs.nvoids.com/job_details.jsp?id=2311245&uid= |
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| 06:28 PM 03-Apr-25 |