Jobs
>
New York City

    Quality Assurance Engineer - New York, United States - 10XBeta Venture Studio

    10XBeta Venture Studio
    10XBeta Venture Studio New York, United States

    3 weeks ago

    Default job background
    Description

    Position Overview

    Join our dynamic startup team as a Quality Assurance Engineer, where you will play a crucial role in ensuring the quality and reliability of groundbreaking medical devices and digital health solutions.

    In your role as a Quality Assurance Engineer, you will primarily develop and manage the various facets of the quality management system, such as CAPA, non-conformance reporting, incoming, in-process, and final inspections, complaint handling, root-cause analysis, metric generation, and be actively involved in both internal and external audits. Additionally, as a key member of our cross-functional team, you will contribute to constructing, evaluating, and appraising the outcomes of product development, encompassing user needs, design and development plans, usability, requirements, design documentation, risk management files, and verification and validation artifacts. Your role is to ensure that these elements align seamlessly with established procedures, standards, and regulatory requirements.

    Key Responsibilities

    1. Develop and maintain manuals, procedures, work instructions, and forms across the quality management system. Administer the Master Document List and maintain the document change request log.

    2. Review and assess project work, including plans, goals, metrics, specifications, test protocols, and risk management documents, ensuring alignment with applicable procedures, standards, and regulatory requirements.

    3. Provide direction and leadership for the quality of digital health technologies, guiding the establishment of product and software requirements, specifications, detailed design, verification, validation, and usability protocols.

    4. Collaborate with project teams to ensure compliance with global ISO standards (ISO 13485, ISO 14971, IEC 6060-1, and IEC 62304), regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, MDD/MDR), and applicable guidance.

    5. Represent quality in technical design reviews, project phase reviews, and problem resolution activities.

    6. Participate in internal and external audits, ensuring the continued suitability and effectiveness of the quality management system.

    7. Interface with customers on quality-related issues.

    Qualifications

    Education:

    Bachelor's degree in Science, Engineering, Systems Engineering, or Biomedical Engineering

    Experience and Skills:

    4 years of experience with a focus on design control, risk management, and verification and validation.

    4 years of Quality experience within the medical device, aerospace, defense, or similarly regulated industry.

    Experience with Data Science and Advanced Statistical Techniques.

    Strong verbal and written communication skills; ability to present issues, plans, and objectives.

    Excellent organizational, problem-solving, and analytical skills.

    Ability to lead priorities and workflow with versatility, flexibility, and a willingness to work within a constantly evolving environment.

    Preferred:

    Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC , IEC 62304, FDAs General Principles of Software Validation.

    Passion for the development and execution of new technologies, including the ability to apply and manage design controls within emerging technologies.

    Join us, a startup with young and talented minds, and contribute to the advancement of technology in the medical field. We are seeking professionals who share our passion and are eager to be part of an innovative and expanding team.

  • 10XBeta Venture Studio

    Quality Assurance Engineer

    2 weeks ago

    10XBeta Venture Studio New York, United States

    Position Overview · Join our dynamic startup team as a Quality Assurance Engineer, where you will play a crucial role in ensuring the quality and reliability of groundbreaking medical devices and digital health solutions. · In your role as a Quality Assurance Engineer, you will p ...

  • CAI

    Quality Assurance Engineer

    5 days ago

    CAI New York, United States

    **Job ID Number** · R2430 · **Employment Type** · Full time · **Worksite Flexibility** · Onsite · **Job Summary** · As the Quality Assurance Engineer, you will be responsible for supporting deployment integration, quality assurance testing, conducting automated and manual ...

  • MediaRadar

    Quality Assurance Engineer

    1 week ago

    MediaRadar New York, United States

    What You've Done: · 3+ years of experience in software quality assurance · Experience with Atlassian Suite (JIRA, Confluence) · Proficiency in programming languages such as Java, Python, or C#. · Strong understanding of software development lifecycle methodologies, including Agi ...

  • Zealthy

    Quality Assurance Engineer

    1 week ago

    Zealthy New York, United States

    About Us: · Zealthy is a telemedicine company on a mission to provide critical healthcare services to all who need them. We are building the world's largest and highest quality telemedicine company and fundamentally expand access to high-quality care. · While the Founder was most ...

  • New York Blood Center

    Quality Assurance Engineer

    3 weeks ago

    New York Blood Center New York, United States

    · Quality Assurance Engineer · Job Locations · US-NY-New York · Job ID · Category · Information Technology · Minimum Rate · USD $125,000.00/Yr. · Maximum Rate · USD $135,000.00/Yr. · Work Location Type · Hybrid · Overview · At New York Blood Center Enterprises (NYBCe), one of th ...

  • 10XBeta Venture Studio

    Quality Assurance Engineer

    3 weeks ago

    10XBeta Venture Studio New York, United States

    Position Overview · Join our dynamic startup team as a Quality Assurance Engineer, where you will play a crucial role in ensuring the quality and reliability of groundbreaking medical devices and digital health solutions. · Candidates should take the time to read all the elemen ...

  • New York Blood Center

    Quality Assurance Engineer

    3 weeks ago

    New York Blood Center New York, United States

    Overview: · At New York Blood Center Enterprises (NYBCe), one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and se ...

  • MediaRadar

    Quality Assurance Engineer

    1 week ago

    MediaRadar New York, United States

    What You've Done: 3+ years of experience in software quality assurance Experience with Atlassian Suite (JIRA, Confluence) Proficiency in programming languages such as Java, Python, or C#. Strong understanding of software development lifecycle methodologies, including Agile and Sc ...

  • iCapital

    Quality Assurance Engineer

    4 days ago

    iCapital New York, United States

    iCapital is powering the world's alternative investment marketplace. Our financial technology platform has transformed how advisors, wealth management firms, asset managers, and banks evaluate and recommend bespoke public and private market strategies for their high-net-worth cli ...

  • aescape

    Quality Assurance Engineer

    1 week ago

    aescape New York, United States

    Aescape is looking for a Quality Assurance Engineer who is skilled at identifying, documenting, and tracking software defects. In this role, you will support our internal systems and ensure they are up and running production software to drive successful internal demos, and tracki ...

  • Zealthy

    Quality Assurance Engineer

    1 week ago

    Zealthy New York, United States

    About Us: · Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required. · Zealthy is a telemedicine company on a mission to provide critical healthcare services to all who need them. We ar ...

  • Zealthy

    Quality Assurance Engineer

    3 weeks ago

    Zealthy New York, United States

    About Us: · Zealthy is a telemedicine company on a mission to provide critical healthcare services to all who need them. We are building the world's largest and highest quality telemedicine company and fundamentally expand access to high-quality care. · While the Founder was mo ...

  • aescape

    Quality Assurance Engineer

    1 week ago

    aescape New York, United States

    Aescape is looking for a Quality Assurance Engineer who is skilled at identifying, documenting, and tracking software defects. In this role, you will support our internal systems and ensure they are up and running production software to drive successful internal demos, and tracki ...

  • iCapital

    Quality Assurance Engineer

    2 days ago

    iCapital New York, United States

    Quality Assurance Engineer - Vice President · iCapital is powering the world's alternative investment marketplace. Our financial technology platform has transformed how advisors, wealth management firms, asset managers, and banks evaluate and recommend bespoke public and private ...

  • Brooksource

    Quality Assurance Engineer

    1 week ago

    Brooksource New York, United States

    Automation Quality Engineer, Video Engineering · Direct-to-Consumer · Responsibilities: · Liaise with product owners and stakeholders to review acceptance criteria and technical specifications · Create and maintain test documentation · Perform a range of behavioral driven develop ...

  • iCapital

    Quality Assurance Engineer

    4 days ago

    iCapital New York, United States Full time

    iCapital is powering the world's alternative investment marketplace. Our financial technology platform has transformed how advisors, wealth management firms, asset managers, and banks evaluate and recommend bespoke public and private market strategies for their high-net-worth cli ...

  • Venusgeo Solutions

    Senior Quality Assurance Engineer

    2 weeks ago

    Venusgeo Solutions New York, United States

    Direct Client is looking for a TWO Different Roles: · 1) Senior Quality Assurance Automation Engineer with experience with UFT and Fidessa. A comprehensive automated trading solution for equities experience from Investment/Banking Domain expertise is a must. · 2) SDET engineers ...

  • aescape

    Senior Quality Assurance Engineer

    1 week ago

    aescape New York, United States

    Develop quality assurance and testing processes for software-based perception, trajectory planning, real-time controls and custom Android-based devices. Build quality assurance standards for robotics frameworks and middleware. Create detailed test plans to ensure high-quality sof ...

  • Pryon

    Quality Assurance Engineering Manager

    2 weeks ago

    Pryon New York, United States

    We are seeking a seasoned Quality Assurance Engineering Manager who will lead QA and oversee all aspects of quality assurance within our engineering and product departments. Reporting directly to the Director of Solutions Architecture and Engineering, this role is pivotal in ensu ...

  • Acro

    Quality Assurance Automation Engineer

    6 days ago

    Acro New York, United States

    The intended automation framework and necessary testing tools must be developed, implemented, and maintained under Azure Stack. Thus, a broad knowledge of Azure services, functions, and tools is required. · Develop and maintain automated test scripts and frameworks to streamline ...