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IT Quality Assurance Jobs in Dallas, TX

Bioinformatics Pipeline Test Engineer

Retail Industry
  • Dallas, Texas
    30+ days ago

    Job Description

     Position Title: Bioinformatics Pipeline Test Engineer
     Domain EXP: (Healthcare Domain)
    Experience: 2+ Years of exp
     Location: San Diego CA “Onsite client office”
    Duration: 6 Months

    JD in brief:
    For these candidates, it’s imperative to have NGS pipeline experience or education. Working with Illumina sequencing data, AWS healthomics, Nextflo Type experience working on secondary analysis pipelines
     
    Essential Duties:
    • VERIFICATION AND VALIDATION
      •  With direction and guidance from the team lead, help with verification and validation protocols and generate test reports for multiple software solutions used in medical devices and LDT products. 
      • Aid in translation of user and software requirements into executable software verification and validation protocols focusing on various aspects of the software lifecycle.
      • Collaborate with bioinformatics scientists and operations to identify test inputs and understand the development of algorithmic test strategy, testing tools, and testing methodology.
      • Test product functionality and/or confirm product capabilities. 
    • DESIGN CONTROLS 
      1. With direction and guidance from the team lead, help with design controls and appropriate software documentation (e.g. software requirements and/or specifications, architecture documents, software design details doc) for medical device software lifecycle. 
      2. Learn and apply best practices for LDT software and create and manage all applicable documentation. 
      3. Participate in risk assessments for software products, including identification of potential risk mitigations and traceability to software requirements. 
      4. Help with the creation of software documentation, compatible with regulatory requirements. 
    • Utilizing standardized procedures and practices, work on assignments individually and with project team members to achieve department and project objectives and meet deadlines.
    • Exercise excellent verbal and written communication skills with the ability to communicate basic technical information.
    • Work towards challenging goals in a fast-moving environment.
    • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
    • Support and comply with the company’s Quality Management System policies and procedures.
    • Maintain regular and reliable attendance.
    • Ability to act with an inclusion mindset and model these behaviors for the organization.
    • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
    • Ability and means to travel 10% between local Exact Sciences locations. 
    • Ability to travel 5% of working time away from work location, may include overnight/weekend/international travel. 
     Minimum Qualifications
    • B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties. 
    • Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications.
    • Familiarity with production software development lifecycle.
    • Familiarity with best practices for software development (such as Git, agile, code reviews, CI/CD). 
    • Ability to effectively communicate software system designs. 
    • Excellent communication skills (both written and oral) with the ability to communicate complicated ideas and information effectively at all levels. 
    • Demonstrated ability to perform the essential duties of the position with or without accommodation.
     Preferred Qualifications
    • Experience with programming languages, ideally Python. 
    • Familiar with automated software testing, preferably in the context of medical devices software such as bioinformatics analysis pipelines. 
    • Familiarity with container orchestration concepts and systems, e.g. Docker, Kubernetes, etc. 
    • Familiar working with cloud platforms (AWS, GCP, Azure).
    • Familiarity within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software. 
    • Familiarity with medical device requirements such as Quality System Regulation (21 CFR part 820) ISO 14971 Medical Device Risk Management, ISO 13485, etc. Work experience is strongly preferred. 
    • Familiarity with bioinformatics analysis pipeline frameworks. 
    • Familiarity with software related Cybersecurity risk management such as FDA Cybersecurity guidance, IEC27000 series, IEC 15408, etc. as well as software audits is a plus.
    Familiar with managing requirements in a validated RM tool such as JAMA, DOORS, etc. 

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.





    Numbers & Facts

    LocationDallas, Texas
    Websitehttps://www.vytwo.com

    Skills

    • Algorithmsunmatched
    • Amazon Web Services (AWS)unmatched
    • Analysis Skillsunmatched
    • Best Practicesunmatched
    • Bioinformaticsunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Business Servicesunmatched
    • Business Transformationunmatched
    • Cloud Computingunmatched
    • Code Reviewsunmatched
    • Code of Federal Regulationsunmatched
    • Communication Skillsunmatched
    • Communications Softwareunmatched
    • Computer Scienceunmatched
    • Consultingunmatched
    • Continuous Deployment/Deliveryunmatched
    • Continuous Integrationunmatched
    • Dockerunmatched
    • Documentationunmatched
    • Enterprise Application Integration (EAI)unmatched
    • FDA (Food and Drug Administration)unmatched
    • Functional Testingunmatched
    • GCP (Good Clinical Practices)unmatched
    • Gitunmatched
    • Healthcareunmatched
    • Healthcare Softwareunmatched
    • ISO (International Organization for Standardization)unmatched
    • Information Technology Consultingunmatched
    • International Electro-Technical Commission (IEC)unmatched
    • Internet Securityunmatched
    • Medical Equipmentunmatched
    • Microsoft Windows Azureunmatched
    • Mobile Devicesunmatched
    • Next Generation Sequencing (NGS)unmatched
    • Polymerase Chain Reaction (PCR)unmatched
    • Presentation/Verbal Skillsunmatched
    • Product Testingunmatched
    • Programming Languagesunmatched
    • Python Programming/Scripting Languageunmatched
    • Quality Assurance Methodologyunmatched
    • Quality Managementunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulatory Requirementsunmatched
    • Reporting Skillsunmatched
    • Requirements Managementunmatched
    • Requirements Validation/Verificationunmatched
    • Risk Managementunmatched
    • Software Administrationunmatched
    • Software Architecture Designunmatched
    • Software Designunmatched
    • Software Developmentunmatched
    • Software Development Lifecycle (SDLC)unmatched
    • Software Engineeringunmatched
    • Software Specificationunmatched
    • Software Testingunmatched
    • Software Validationunmatched
    • Strategic Planningunmatched
    • System Integration (SI)unmatched
    • Team Lead/Managerunmatched
    • Team Playerunmatched
    • Test Automationunmatched
    • Test Strategyunmatched
    • Test Toolsunmatched
    • Testingunmatched
    • Time Managementunmatched
    • Typingunmatched
    • Validation Planunmatched
    • Validation Testingunmatched
    • Willing to Travelunmatched
    • Writing Skillsunmatched
    • eBusinessunmatched

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