Software Quality Engineer - - role at Advantage Resourcing

Advantage Resourcing
Published
September 16, 2020
Location
Pittsburgh, PA
Job Type
Job Expires: 2020-12-15

Description

Apply You will be redirected to Advantage Resourcing's preferred application process.

Software Quality Engineer - Remote-Work From Home role initially

Software Quality Engineers
- Medical Devices or FDA and Application Software

Looking for Software Quality Engineers Remote Work From Home Initially
Locations: Pittsburgh, PA
- Will start as a Remote-Work From Home role initially and will eventually be onsite in Pittsburgh, PA once the day to day life returns to normalcy in the country
Not sure if this location is of interest to you
Duration: Temp to Hire
If interested, please respond with resume
No vendor submissions
- Independent Consultants only with no 3rd party involved
No C2C / No Corp to Corp / No 1099 / No H1 B / No CPT or OPT at this time

Responsibilities and Role:
Assure quality in design for medical devices and application software, compliant with domestic and international regulations, standards, and applicable guidance documents.
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.
Review verification and validation test plans, test procedures, and test reports, and monitor progress to resolve anomalies in a bug tracking system.
Assure quality and compliance.
Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements.
Support 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.
Support the planning of software development tasks, writing software design input requirement specifications, performing risk assessment, and completing DFMEAs on software elements.

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

DESIRED EXPERIENCE: (NOT REQUIRED BUT A HUGE PLUS IF YOU HAVE)
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 HP ALM and HP QC;
Developing automation code in C# using MS Visual Studio; and
Ensuring compliance to product specific standards, cGMP, QSR, US FDA requirements.
Quality Engineering Certification (ASQ
- CQA/ CQE) or equivalent
ISO 13485:2016 Auditor Certification preferred
Software development using ISO/IEC 62304
Risk Management using ISO/IEC 14971
Experience working in regulated industries, preferably medical device, including FDAs 21 CFR 820/ISO 13485

Looking for Software Quality Engineers Remote Work From Home Initially
Locations: Pittsburgh, PA
- Will start as a Remote-Work From Home role initially and will eventually be onsite in Pittsburgh, PA once the day to day life returns to normalcy in the country
Not sure if this location is of interest to you
Duration: Temp to Hire
If interested, please respond with resume
No vendor submissions
- Independent Consultants only with no 3rd party involved
No C2C / No Corp to Corp / No 1099 / No H1 B / No CPT or OPT at this time

Responsibilities and Role:
Assure quality in design for medical devices and application software, compliant with domestic and international regulations, standards, and applicable guidance documents.
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.
Review verification and validation test plans, test procedures, and test reports, and monitor progress to resolve anomalies in a bug tracking system.
Assure quality and compliance.
Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements.
Support 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.
Support the planning of software development tasks, writing software design input requirement specifications, performing risk assessment, and completing DFMEAs on software elements.

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

DESIRED EXPERIENCE: (NOT REQUIRED BUT A HUGE PLUS IF YOU HAVE)
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 HP ALM and HP QC;
Developing automation code in C# using MS Visual Studio; and
Ensuring compliance to product specific standards, cGMP, QSR, US FDA requirements.
Quality Engineering Certification (ASQ
- CQA/ CQE) or equivalent
ISO 13485:2016 Auditor Certification preferred
Software development using ISO/IEC 62304
Risk Management using ISO/IEC 14971
Experience working in regulated industries, preferably medical device, including FDAs 21 CFR 820/ISO 13485

About Advantage Resourcing

Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.

SDL2017

Apply You will be redirected to Advantage Resourcing's preferred application process.

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