| Looking Onsite || Sr. Software Quality Engineer (CSV) || Puerto Rico, TX (Onsite) at Rico, Colorado, USA |
| Email: [email protected] |
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From: Gaurav, Quantum World IT [email protected] Reply to: [email protected] Greeting, I hope all is well with you For the following, Quantum World IT is seeking the best consultant profile. Please respond with your most recent resume if you are considering new opportunities. Looking Onsite || Sr. Software Quality Engineer (CSV) || Puerto Rico, TX (Onsite) Essential Skills: Sr. Software Quality Engineer 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 Desirable Skills: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation department. Implement new or changed programs/policies/procedures related to CSV and support SDLC & software validation policies, procedures and processes for computerized systems. Facilitate change validation as part of the Change Control Board (CCB) as the SQE representative. Lead the Installation Qualification (IQ) of manufacturing lines. Support CSV improvement initiatives in manufacturing. Champion cross-collaboration across functions, sites and operating companies in the area of CSV. Identify and resolve barriers that impede business needs. Collaborate with Franchise Quality in the deployment (design, implementation, and post-monitoring) of Quality System initiatives impacting the site that promote the continuous improvement of the Quality System and ensure continuity of the application of globally shared processes and systems at the site level. Support compliance activities by participating in audit readiness, support internal and external audits pertaining to CSV. Serve as the Subject Matter Expert for CSV and manage investigations, responses, and remediation of site-specific CSV audit observations Keywords: CSV, SDLC, CCB, IQ, URS, SDS and RTM Please enter the following information is needed for submission and Photo id Position Applied for | | Candidate Full Name [As per Passport] | | Contact Number Primary & Secondary | | Current Location | | Email | | Work Authorization | | Total years of Experience | | Had ever worked with TCS in Past (Required filed) | | Have you gotten covid Vaccination does | | LinkedIn ID | | Are you comfortable for on-site | | Rate | | Gauarv Kumar Phone: +1 8053915957 Email: [email protected] Quantum World Technologies Inc. 4281 Katella Ave, Suite #102 Los Alamitos CA 90720 USA Keywords: information technology California Idaho Texas Looking Onsite || Sr. Software Quality Engineer (CSV) || Puerto Rico, TX (Onsite) [email protected] |
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| 04:19 AM 01-Feb-25 |