Software Quality Engineer at US Tech Solutions in State College, PA

US Tech Solutions
September 16, 2020
State College, PA
Job Type


Apply You will be redirected to US Tech Solutions's preferred application process.

Software Quality Engineer

Job Description US Tech Solutions is seeking a ldquo
Software Quality Engineerrdquo for a 8 Months contract (Temporary contractor to permanent conversion) position with a client in Pittsburg PA Remote until pandemic situation subsides Job Poster Roshan Debanjan Shah The Software Quality Engineerinteracts with the project team to assure quality in design for MEDICAL DEVICES and application software, compliant with domestic and international regulations, standards, and applicable guidance documents. You Review Design Inputs, testing strategies, and test procedures (both manual and automated) and interact with the project team to help write and conduct, or review document design specifications and unitintegrationverification tests. You will be responsible for risk assessment, complete and coach engineers in completing FMEAs and other analysis of elements, review verification and validation test plans, test procedures, and test reports, and monitor progress to resolve anomalies in a bug tracking system. You will advise on completing product requirements, risk controls, unit tests, integration tests, design reviews, specification traces, verificationvalidation testing, and bug tracking. You will mentor staff on validation methods that maintain compliance with regulations and standards and advice on use of quality assurance methods in development, release, and maintenance of software used in production, testing, and service functions. As a Software Quality Engineer, you will be expected to bull Oversee software design change projects to assure quality and compliance. bull Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specificationsstandards and that the safety and reliability of products are established. bull Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements. bull Generateapprovemanage software and design verifications, design validations, reliability testing, process validations, supplier qualifications, test methods, capability studies, and risk management documentation. bull Lead verification and validation of embedded software, analog and digital electronic circuits, and support hardware used within instrument products for FDA 510k, CE Mark, and international regulatory approvals. bull Interface with RD and manufacturing engineers to identify and resolve defects and product quality issues. bull Lead project cross-functional communication of status and deliverables towards product development milestones and submission filings, including design reviews, risk management, requirements and verification traceability. bull Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis. bull Work with outside labs and suppliers to communicate clientrsquos productprocess requirements as well as assess capabilities of the outside labsupplier. bull Complete product risk assessment, incorporating contributions from various functions bull Review and approve software requirement specifications and associated traces. bull Complete CSV on Quality System Tools bull Work with engineering staff in planning software development tasks, writing software design input requirement specifications, performing risk assessment, and completing DFMEAs on software elements. bull Review and approve software unit tests. bull Review and advice on system verification and validation test plans and test procedures. Education bull Bachelorrsquos Degree in Engineering, Computer, or other Science discipline, with 2 -4 years of experience in software testing. Licenses
Certifications Preferred bull Quality Engineering Certification (ASQ
- CQA CQE) or equivalent bull ISO 134852016 Auditor Certification preferred Experience and Competencies bull Working knowledge of requirement and design specifications, risk assessments, specification traces, unit tests, integration tests, regression tests, user interface, automated testing, and designcode reviews. bull Quality mentality and thinking outside the box, ability to envision multi-product relationships bull Software development using ISOIEC 62304 bull Risk Management using ISOIEC 14971 bull Experience working in regulated industries, preferably medical device, including FDArsquos 21 CFR 820ISO 13485 Additional Experience Desired bull BDDTDD, Linux, Angular, React CLI, Jest, Specflow
Cucumber bull Experience with test automation and management tools, such as Jasmine, JUnit, NUnit, Cucumber, Spec
Flow bull Experience using Java
Script, Gradle, Git, JUnit, andor NUnit bull Experience writing code in Java
Script, C, or Java bull Experience testing on IOS and Android operating systems bull Experience working with Agile methods, including SAFe bull Experience developing and executing manual and automated test suites bull Experience working in a variety of programming languages and environments bull Performing requirements management and defect tracking bull Preparing and executing test cases using Client ALM and Client QC bull Developing automation code in C using MS Visual Studio and bull Ensuring compliance to product specific standards, cGMP, QSR, US FDA requirements. About US Tech Solutions Your talent, our opportunities
- This is the premise behind US Tech Solutions. You have the skill we have the opportunity. As a team, we work passionately for you to get the right career opportunity across industry verticals and functions. For past sixteen years, leading Global Companies and Fortune 500 come to us to get the right talent. Whether you want to work as full-time, contractor or part-time, technical or non-technical our talent consultants will connect with the right career opportunity globally. Connect with our talent team today.
USTECH was founded in 2000 by Manoj Agarwal. Today, we are a global firm offering talent solutions to 150 customers including 20 of Fortune 500 across Financial Services, Healthcare, Life Sciences, Aerospace, Energy, Retail, Telecom, Technology, Manufacturing, and Engineering. We are headquartered in New Jersey with 40 global locations across the USA, Canada, Europe, and India. Deloitte has recognized USTECH as one of the fastest growing private businesses for the past five consecutive years and INC 500 for the past three. We have also been rated ldquoThe Top Business in the US" by Diversity Business since 2011. To learn more about how US Tech Solutions visit our website ldquoUS Tech is an Equal Opportunity Employer" and ldquos all other parties authorized to work in the US are encouraged to apply." Apply Interested candidates are requested to send their resume to Roshan at

Job Expires: 2020-12-15
Apply You will be redirected to US Tech Solutions's preferred application process.

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