16 days old

Quality Engineer

Kelly Services
Pittsburgh, PA 15222
**Title:** Software Quality Engineer II

**Work Location:** Pittsburgh Pennsylvania USA 15222

**Duration:** 08/31/2020 to 04/30/2021

**MUST HAVE life science or Med Device experience**

Please send resumes to

**This role could be Temp to Perm**

+ 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 communicate Smith & Nephew 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.


+ Bachelors 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 FDAs 21 CFR 820/ISO 13485


+ BDD/TDD, Linux, Angular, React CLI, Jest, Specflow/Cucumber

+ Experience with test automation and management tools, such as Jasmine, JUnit, NUnit, Cucumber, SpecFlow

+ Experience using JavaScript, Gradle, Git, JUnit, and/or NUnit

+ Experience writing code in JavaScript, 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.

Thank you!

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Posted: 2020-10-12 Expires: 2020-11-12

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Quality Engineer

Kelly Services
Pittsburgh, PA 15222

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