Quality Assurance Engineer

4 weeks ago

New York, United States 10XBeta Venture Studio Full time

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 60601-1, IEC 62304, FDA’s 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.

  • Quality Assurance Engineer

    3 weeks ago

    New York, New York, United States GForce Life Sciences Full time

    A Senior Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system.Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business...

  • Quality Assurance Engineer

    3 hours ago

    New York, United States The Metrix Company Full time

    The Metrix Company, a leading medical device manufacturer, is seeking an experienced Quality Assurance Engineer to assist in maintaining the company's Quality Management System. Responsibilities Assists in maintaining the company’s Quality Management System (QMS) and assists in the review and development of standard operating procedures, which support...

  • Quality Assurance Engineer

    4 weeks ago

    New York, United States 10XBeta Venture Studio Full time

    Position OverviewJoin 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...

  • Quality Assurance Engineer

    4 weeks ago

    New York, New York, United States Amazon Full time

    You should have a demonstrated track record of delivering test automation quality requirements designing performance and scale test suites and producing deliverables that exceed commitments. You should also be comfortable presenting technical material to internal and external audiences in support of our customers. Candidates should be able to develop test...

  • Quality Assurance Engineer

    4 weeks ago

    New York County, New York, United States New York Blood Center Inc Full time

    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 service development. Join us as we work towards meeting and exceeding the growing...

  • Quality Assurance Engineering Manager

    3 days ago

    New York, NY, United States Pryon Full time

    New York CityForward Engineering /Full Time /HybridWe 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 ensuring the reliability,...

  • Senior Quality Assurance Engineer

    3 days ago

    New York, United States Venusgeo Solutions Full time

    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 with investment and trading platform applications testing background is a must.TWO...

  • Senior Quality Assurance Engineer

    3 days ago

    New York, United States Venusgeo Solutions Full time

    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 with investment and trading platform applications testing background is a must.TWO...

  • Quality Assurance Engineer

    3 hours ago

    New York, United States Carlisle Fluid Technologies Full time

    Summary: The Senior Quality Assurance Engineer role is a crucial part of the Carlisle Fluid Technologies (CFT) Twin Cities Operations leadership team covering the Oakdale and Blaine, MN facilities. The position reports to the Director of Operations and is responsible for driving the overall Quality Management System (QMS), and strategic and tactical quality...

  • Quality Assurance Manager

    1 week ago

    New York, United States Astrix Inc Full time

    A leader within the Medical Device industry is seeking an experienced Quality Assurance Manager to lead their site in the Buffalo area. This will be a temporary position lasting 6+ months. Responsibilities: Serve as the site lead of quality assurance and the management representative of large scale manufacturing site. Manage, maintain, and continuously...

  • Quality Assurance Manager

    4 days ago

    New York, United States Astrix Inc Full time

    A leader within the Medical Device industry is seeking an experienced Quality Assurance Manager to lead their site in the Buffalo area. This will be a temporary position lasting 6+ months. Responsibilities: Serve as the site lead of quality assurance and the management representative of large scale manufacturing site. Manage, maintain, and continuously...

  • Quality Assurance Manager

    1 week ago

    New York, United States Cyfle Full time

    About the job Quality Assurance Manager Salary: $ 126,500.00We have partnered with a large non-profit organization in the New York, NY area to provide them with a Quality Assurance Manager. Please review the below description and let us know if you are interested. Must Have Skills for the Quality Assurance Manager:#1. 7+ years background in IT (preferably in...

  • Sr Quality Assurance Manager

    2 weeks ago

    New York, United States Brunel Full time

    Position Overview: Brunel is seeking a highly skilled and experienced Senior Manager of Quality Assurance to join our MA-based client. The Senior Manager of Quality Assurance will be responsible for overseeing all aspects of quality assurance activities related to the design, development, manufacturing, and distribution of their Class II medical devices....

  • Quality Engineer

    3 weeks ago

    New York, United States Plastic Executive Recruiters Full time

    Job description We are seeking a skilled Quality Engineer with expertise in the plastics extrusion or general plastics industry. As a Quality Engineer, your role will involve ensuring product quality, implementing quality assurance measures, and driving continuous improvement. You will develop quality standards, conduct inspections, analyze data, and...

  • Quality Assurance Analyst

    3 hours ago

    New York, United States VOHRA Wound Physicians Full time

    Position : Quality Assurance Analyst (QA) Location : Hybrid (4-days in office/ 1-day WFH) at 3601 SW 160th Ave, Ste 250, Miramar, FL, 33027 Vohra Wound Physicians is a dynamic and innovative physician management group with cutting edge proprietary systems. The company is currently looking for a highly technical and detailed Quality Assurance Analyst with...

  • Quality Assurance Engineer

    6 hours ago

    New York, United States Zealthy Full time

    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 are building the world's largest and highest quality telemedicine company and...

  • Quality Assurance Supervisor

    2 weeks ago

    New York, United States DSA Doors Full time

    We are DSA Doors, a leading wood door manufacturer headquartered in Raleigh, NC, is seeking a talented and motivated Quality Assurance Supervisor. We invite you to join our team and contribute to maintaining and enhancing DSA's reputation for high-quality products. In this pivotal role, you will play a crucial part in supporting and continuously improving...

  • Quality Assurance Engineer

    3 weeks ago

    New York, United States Zealthy Full time

    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 recently Founder and CEO at a unicorn healthcare company, the full-time team is...

  • Quality Assurance Engineer

    3 weeks ago

    New York, United States Zealthy Full time

    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 recently Founder and CEO at a unicorn healthcare company, the full-time team is...

  • Quality Assurance Specialist

    3 weeks ago

    New York, United States Work Visa USA Jobs (move2usajobs.com LLC) Full time

    An outstanding opportunity is available for Quality Assurance Specialists looking to bring their expertise and precision to the United States. This role is crafted for professionals dedicated to ensuring product and service excellence, enhancing customer satisfaction, and contributing to the continuous improvement of processes within a vibrant market. Ideal...