CAPA Software Quality Engineer at Remote, Remote, USA |
Email: [email protected] |
http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=920904&uid= From: Mohit, 1 Point System [email protected] Reply to: [email protected] Hi Hope you are doing well. My name is Mohit Sharma, and I am a Staffing Specialist at 1Point System LLC. I am reaching out to you on an exciting job opportunity with one of our clients. Role: - Software Quality Engineer Location: - Mt Prospect, IL Job Type: - Long Term Contract USC or GC and local Skills:- FCA , SCAR , CAPA Job Description Hybrid Schedule- Yes, but only after initially spending 100% in the office 3-6 months Responsibilities: Able to define design document requirements for process and test method validation within Design Control and Software Development Life Cycle {SDLC). Supports CAPA {Corrective Action Preventive Action) and FCA (Field Corrective Action) activities as required. Supports supplier qualification and maintenance activities. Performs SCAR {Supplier Corrective Action), and process deviation activities. Qualifications: Bachelors Degree in a scientific or technical discipline preferred or 10+ years of experience in a related field. 1+ year in a regulated environment, preferably in medical devices with knowledge of quality system processes. Experience in applying quality regulations and standards {e.g., 21CFR 820, ISO 13485, ISO 14971, IEC62304, Cybersecurity- ISO 27001), and working knowledge of current and applicable GMP regulations is required. Experience in reviewing, and executing validation and change control documents, authoring SOPs, Protocols {IQ, OQ, PQ) of Process Control Systems Demonstrates project management skills. Best Regards, Mohit Sharma Sr. Recruiter 1Point System LLC [email protected] || www.1pointsys.com linkedin.com/in/mohit-sharma-59900a167 115 Stone Village Drive Suite C Fort Mill, SC 29708 Keywords: access management green card Illinois Montana South Carolina http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=920904&uid= |
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03:35 AM 08-Dec-23 |