| Urgent openings for Validation Engineer - Medical Device & Regulations required in Dallas, TX -Day 1 onsite at Dallas, Texas, USA |
| Email: [email protected] |
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From: Priya Mishra, KKsoftwareassociates [email protected] Reply to: [email protected] Hello, Hope you are doing good. This is Priya from KK Software Associates LLC. We are the Preferred vendor for the clients. I found your resume suitable for one of the job opportunities we currently have. Please find the detailed job description and please do let me know if you are interested in this opening: Role name: Validation Engineer - Medical Device & Regulations Location: Dallas, TX -Day 1 onsite Contract Experience (Years): 10 & Above Role Description: Validation, CSV, IQ, OQ ,PQ, FAT, SAT, Technical writer, documentation Competencies: EIS : Medical Device & Regulations Essential Skills: Technical Writer & Validation Support Minimum of 3 Yr exp supporting the validation of a major capital automation projectsTechnical Writing Skills1. Writing and Editingo Strong writing, grammar, and editing abilities to create clear and concise documentation.o Ability to adapt writing style to various audiences (e.g., end users, technical teams, or regulatory bodies).2. Document Design and Formattingo Proficiency with documentation tools (e.g., Microsoft Word, Adobe FrameMaker, or Google Docs).o Knowledge of design principles to create well-structured documents (manuals, user guides, SOPs, etc.).3. Version Controlo Familiarity with tools like Git, SVN, or SharePoint to manage document revisions and updates.4. Understanding of Documentation Standardso Familiarity with documentation standards such as DITA (Darwin Information Typing Architecture) or the S1000D standard.o Ability to create and maintain templates, style guides, and consistency in documentation.5. Technical Communication Toolso Experience with tools like Confluence, MadCap Flare, or HelpNDoc for creating and managing online help systems and documentation.Validation Support Skills1. Validation Knowledgeo Understanding of validation processes, especially in regulated industries (e.g., healthcare, pharmaceuticals, or software validation).o Knowledge of validation protocols like IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).2. Quality Management Systems (QMS)o Familiarity with industry standards like ISO 9001, FDA regulations (21 CFR Part 11), and GxP (Good Laboratory Practice, Good Manufacturing Practice) guidelines.o Ability to support validation documentation, such as test plans, test scripts, and validation reports.3. Testing and Documentationo Knowledge of validation testing procedures and the ability to document results accurately.o Experience with creating and maintaining test documentation, logs, and records.4. Regulatory Complianceo Knowledge of relevant regulatory standards and ensuring that validation documentation meets those requirements.5. Cross-Functional Collaborationo Ability to work with technical teams (engineers, developers, QA, and project managers) to understand and document requirements, as well as support validation efforts.6. Work experience in the medical device industry Desirable Skills: Management of document tracker (Actively updating the document Listing of all documents for review | approval). This includes following up with reviewers / approvers, to ensure documents are reviewed / approved on time. FAT & SAT Documentation creation. FAT & SAT Protocol and Test Plan Completed. Validation documentation creation. IQ | OQ | PQ Documentation creation. IQ | OQ | PQ Documentation Plan Completed. Action plan developed for each of the key deliverables. Support the execution of IQ, OQ & PQ Testing 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 in Engineering, or a related technical field. Thanks & Regards, Priya Mishra Lead US IT Recruiter 8751 Collin McKinney Pkwy, # 1302, McKinney, TX 75070 555 Metro Place North, Suite # 100, Dublin, OH 43017 Email: Priya.m @kksoftwareassociates.com Web: www.kksoftwareassociates.com Keywords: quality analyst information technology Ohio Texas Urgent openings for Validation Engineer - Medical Device & Regulations required in Dallas, TX -Day 1 onsite [email protected] |
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| 11:44 PM 28-Jan-25 |