| Quality Validation Engineer(Medical Device & Regulations, Life Sciences) at Jacksonville, Florida, USA |
| Email: [email protected] |
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From: Navneet, Siriinfo [email protected] Reply to: [email protected] Hello, My Name is Navneet Jha. I am reaching out to you today because we have your resume in our database and wanted to check if you are currently available in the market actively looking for an opportunity. Please see the below mentioned requirement and I believe you would be a good match for the role. I would appreciate if you could respond with your updated resume along with the good time to speak so we can move forward with the process. Role: Quality Validation Engineer(Medical Device & Regulations, Life Sciences) Location: Jacksonville, FL- onsite Duration: Contract to Hire Mode: Video Role Description: CSV, SDLC, CCB, IQ, URS, SDS and RTM Competencies: EIS : Medical Device & Regulations, Life Sciences : Computer System Validation Experience (Years): 2-4 Essential Skills: 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 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 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 Must have very good written and verbal communication skills. Customer support experience preferred. Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Employee must be able to effectively prioritize and manage multiple activities and responsibilities. Ability to function in a team environment and deliver on team objectives is required. Ability to make decisions and solve problems while exhibiting situational judgement. Bachelors Degree is required, preferably in Engineering,Computer Science or a related technical field Best Regards, Navneet Jha D : 848-999-0314 | Email: [email protected] Siri InfoSolutions Inc, 3 Ethel Rd, Suite # 302, Edison NJ 08817. CPUC Certified We respect your online privacy. If you would like to be removed from our mailing list please reply with "Remove" in the subject and we will comply immediately. We apologize for any inconvenience caused. Please let us know if you have more than one domain. Keywords: access management Florida New Jersey Quality Validation Engineer(Medical Device & Regulations, Life Sciences) [email protected] |
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| 04:15 AM 07-Mar-25 |