Software Quality Engineer at US Tech Solutions

US Tech Solutions
Published
September 16, 2020
Location
Pittsburgh, PA
Job Type
Job Expires: 2020-12-15

Description

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

Software Quality Engineer

Job Description

US Tech Solutions is seeking a Software Quality Engineer 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 Engineer interacts 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 unit/integration/verification 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, verification/validation 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:
Oversee software design change projects to assure quality and compliance.
Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established.
Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements.
Generate/approve/manage software and design verifications, design validations, reliability testing, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.
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.
Interface with R&D and manufacturing engineers to identify and resolve defects and product quality issues.
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.
Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.
Work with outside labs and suppliers to communica
te client s product/process requirements as well as assess capabilities of the outside lab/supplier.
Complete product risk assessment, incorporating contributions from various functions
Review and approve software requirement specifications and associated traces.
Complete CSV on Quality System Tools
Work with engineering staff in planning software development tasks, writing software design input requirement specifications, performing risk assessment, and completing DFMEAs on software elements.
Review and approve software unit tests.
Review and advice on system verification and validation test plans and test procedures.

Education
Bachelor s Degree in Engineering, Computer, or other Science discipline, with 2 -4 years of experience in software testing.

Licenses/Certifications Preferred
Quality Engineering Certification (ASQ
- CQA/ CQE) or equivalent
ISO 13485:2016 Auditor Certification preferred

Experience and Competencies
Working knowledge of requirement and design specifications, risk assessments, specification traces, unit tests, integration tests, regression tests, user interface, automated testing, and design/code reviews.
Quality mentality and thinking outside the box, ability to envision multi-product relationships
Software development using ISO/IEC 62304
Risk Management using ISO/IEC 14971
Experience working in regulated industries, preferably medical device, including FDA s 21 CFR 820/ISO 13485

Additional Experience Desired:
BDD/TDD, Linux, Angular, React CLI, Jest, Specflow/Cucumber
Experience with test automation and management tools, such as Jasmine, JUnit, NUnit, Cucumber, Spec
Flow
Experience using Java
Script, Gradle, Git, JUnit, and/or NUnit
Experience writing code in Java
Script, C#, or Java
Experience testing on IOS and Android operating systems
Experience working with Agile methods, including SAFe
Experience developing and executing manual and automated test suites
Experience working in a variety of programming languages and environments
Performing requirements management and defect tracking;
Preparing and executing test cases using Client ALM and Client QC;
Developing automation code in C# using MS Visual Studio; and
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 The Top Business in the US" by Diversity Business since 2011. To learn more about how US Tech Solutions visit our website: www.ustechsolutions.com.

US Tech is an Equal Opportunity Employer" and US Citizens & 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 ...@ustechsolutionsinc.com

Job Requirements:

Job Description

US Tech Solutions is seeking a Software Quality Engineer 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 Engineer interacts 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 unit/integration/verification 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, verification/validation 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:
Oversee software design change projects to assure quality and compliance.
Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established.
Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements.
Generate/approve/manage software and design verifications, design validations, reliability testing, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.
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.
Interface with R&D and manufacturing engineers to identify and resolve defects and product quality issues.
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.
Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.
Work with outside labs and suppliers to communica
te client s product/process requirements as well as assess capabilities of the outside lab/supplier.
Complete product risk assessment, incorporating contributions from various functions
Review and approve software requirement specifications and associated traces.
Complete CSV on Quality System Tools
Work with engineering staff in planning software development tasks, writing software design input requirement specifications, performing risk assessment, and completing DFMEAs on software elements.
Review and approve software unit tests.
Review and advice on system verification and validation test plans and test procedures.

Education
Bachelor s Degree in Engineering, Computer, or other Science discipline, with 2 -4 years of experience in software testing.

Licenses/Certifications Preferred
Quality Engineering Certification (ASQ
- CQA/ CQE) or equivalent
ISO 13485:2016 Auditor Certification preferred

Experience and Competencies
Working knowledge of requirement and design specifications, risk assessments, specification traces, unit tests, integration tests, regression tests, user interface, automated testing, and design/code reviews.
Quality mentality and thinking outside the box, ability to envision multi-product relationships
Software development using ISO/IEC 62304
Risk Management using ISO/IEC 14971
Experience working in regulated industries, preferably medical device, including FDA s 21 CFR 820/ISO 13485

Additional Experience Desired:
BDD/TDD, Linux, Angular, React CLI, Jest, Specflow/Cucumber
Experience with test automation and management tools, such as Jasmine, JUnit, NUnit, Cucumber, Spec
Flow
Experience using Java
Script, Gradle, Git, JUnit, and/or NUnit
Experience writing code in Java
Script, C#, or Java
Experience testing on IOS and Android operating systems
Experience working with Agile methods, including SAFe
Experience developing and executing manual and automated test suites
Experience working in a variety of programming languages and environments
Performing requirements management and defect tracking;
Preparing and executing test cases using Client ALM and Client QC;
Developing automation code in C# using MS Visual Studio; and
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 The Top Business in the US" by Diversity Business since 2011. To learn more about how US Tech Solutions visit our website: www.ustechsolutions.com.

US Tech is an Equal Opportunity Employer" and US Citizens & 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 ...@ustechsolutionsinc.com

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

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