Software Quality Engineer job in Plano, TX
Vacancy has expired
Plano, TX CorTech LLC
| Job Ref: | 346063 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 55.36/Per Hour |
| Remote: | No |
Location |
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| City: | Plano, TX |
| Post Code: | 75024 |
| Map: |
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Description |
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CorTech is seeking to hire a Software Quality Engineer for our client in Plano, TX! Benefits Available! Weekly Pay! $55.36/Hour Start Time (AM/PM) 9:00am End Time (AM/PM) 6:00pm This is a non-exempt position. Working independently under limited supervision, performs highly complex and specialized level software project activities in such areas as Development, Tools, Test, Requirements and/or related areas. Assignments may include, but are not limited to, analyzing requirements, planning and scheduling data, updating and maintaining different software specifications based on analysis of specifications, needs and improvements, as well as troubleshooting, debugging, and maintaining of software, test, or tool designs, cases, scripts, procedures, and/or code based on strategic analysis. Functions as lead on project teams and may supervise other engineers. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of specialized study. Applies engineering and scientific principles to the evaluation and solution of technical problems in a creative manner unique to each study. Exercises level appropriate technical judgment in planning, organizing, performing, and/or coordinating engineering work. Duties: Working from requirement specifications, develops, maintains, and updates detailed design and interface specifications. Participates in and supports the implementation, development, enhancements, and modifications to software source code, scripts, and procedures; Debugs, troubleshoots, and isolates software problems as well as offers strategic solutions, analysis, and advice regarding identified issues for future development; Identifies parameters, structure, and critical test components. Writes, updates, or executes test design, cases, as well as procedures and reports results. Writes, updates, and maintains requirement and interface specifications; Contributes to and supports gathering, analyzing, and validating requirements; Contributes to and supports writing, updating, developing and maintaining Hazard/Risk analysis specifications; Contributes to and supports root-cause analysis of failures. Working from requirement specifications, develops, maintains, and updates test requirements and design; Supports implementation, enhancements, and modifications to test cases, procedures, scripts, and code; Debugs, troubleshoots, and isolates software problems and offers strategic advice regarding identified issues for future development; Identifies parameters, structure, and critical test components. Writes, updates, or executes test design, cases, as well as procedures and reports results. Presents at design reviews; documents and resolves issues as directed. Contributes to and supports reviews held by other engineers on related projects and provide useful feedback. Contributes to and supports a variety of test phase efforts. May write and update requirement specifications for an assigned area. Reviews project deliverables such as specifications, code, and test/tool procedures for feasibility, thoroughness, clarity, correctness, and accuracy. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. Qualifications: Bachelor's degree in software engineering, computer science, or a related engineering field. Typically a minimum of ten plus years of progressively more responsible work experience in a range of software engineering disciplines using a variety of programming methods Experience with visual modeling, graphical user interfaces, multi-threading, networking, relational databases, formal software development methodologies, and source code management is recommended. Experience with unit- and integration-level testing and automated testing is recommended. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 10%, including internationally. Ability to maintain regular and predictable attendance. Extensive experience as a Software Quality Engineer, Design and Development Quality Engineer with experience in the FDA design controls and risk management System Development Life Cycle (SDLC), familiar with Waterfall, V-shape model, and agile mode also Experience in Statistical Process Control (SPC) Methodologies and best practices. Experience in multiple SDLC methodologies, IQ/OQ/PQ/TMV/Software Validation in system & quality and Solid command of technologies, tools, and best practices in Testing, Verification & Validation activities, Technical Documentation (IQ/OQ/PQ) in Compliance to FDA regulations, Risk Analysis SME (DFMEA, PFMEA). Strong knowledge of SDLC by FDA requirements and ISO standard 62304; strong experience with validation documentation URS, FRS, SDS, IQ, OQ, and PQ follow Compliance regulatory requirements. conducting Acceptance testing, Ad Hoc testing, Beta testing, Compatibility testing, remediation, End-to-End testing, Recovery testing, Functional testing, Regression testing, Integration testing, performance testing, Load/Stress testing, Smoke testing, and System testing in the validation of IOS (software and hardware) and project management in Share point. PROFESSIONAL EXPERIENCE Software Quality Engineer Managed audits, including planning, supervising, conducting, following up, and supporting auditing techniques in a QMS environment with Computerized Maintenance Management (CMMS) systems completed review and revision of the Complaint / CAPA system to align with Software Development Life Cycle (SDLC), FDA, cGMP, 803, 806, MDD, CE, EU requirements and provides technical remediation guidance and support. Software Quality Engineer Performed eQMS database(s) and Computerized Maintenance Management (CMMS) systems, Software Development Life Cycle (SDLC), Software verification and validation including a training program for relevant disciplines to participate in the evaluation of vendor Quality Management Systems (QMS) to meet business objectives. Managing testing starting from protocols to review of reports from verification and validation engineers which act as design quality engineer?s extended team with Compliance to Quality Management System and Design Controls in Risk Management, Report (RMR) all AFAP (As Far as Possible)/High risks are adequately addressed from the DCRM and Production Risk Management (PRM/PFMEA) documents. Education Master?s in engineering management | |
ref: (346063)
1052 days ago
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