Quality Engineer

2 days ago

Jacksonville, FL, United States CData Software Full time

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.? Good to have: Experience with SCADA and/or Manufacturing Execution Systems (MES) and experience working in manufacturing/operations.? Medical device process validation Or Software Quality testing 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. ? 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 testdocumentation.? Prioritize and plan all assigned projects for the software validation department.? Implement new or changed programs/policies/procedures related to CSV andsupport SDLC & software validation policies, procedures and processes forcomputerized systems.? Facilitate change validation as part of the Change Control Board (CCB) as theSQE representative.? Lead the Installation Qualification (IQ) of manufacturing lines.? Support CSV improvement initiatives in manufacturing.? Champion cross-collaboration across functions, sites and operating companies inthe 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 internaland 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

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