Jobs
>
Irvine

    Sr. Quality Assurance Engineer - Irvine, United States - PRISMATIK DENTALCRAFT, INC.

    PRISMATIK DENTALCRAFT, INC.
    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    3 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Position at Prismatik Dentalcraft, a subsidiary of Glidewell

    Essential Functions:

    • Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices.
    • Responsible for the administration of the QMS software.
    • Collaborates with software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices.
    • Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements.
    • Integrates ISO 14971, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes.
    • Mentors and provides direction to software development teams in design controls and lead risk management activities.
    • Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework.
    • Provides CAPA, complaints, audit and overall QMS support in regards to software.
    • Performs other related duties and projects as business needs require at direction of management.

    Education and Experience:

    • Bachelor's degree in Computer Science, Software Engineering, Informatics, Biomedical, or related technical field or equivalent practical experience.
    • Minimum of eight (8) years of experience in software design assurance in the FDA QSR/ISO 13485 medical device industry.
    • Experience with the application of IEC Medical Device Software Lifecycle Processes), ISO Risk management) and IEC 62366 Usability Engineering.
    • Experience with Agile software development methodologies like Scrum and Kanban.
    • Experience with other than embedded software development areas, such as web development.
    • Previous experience with digital health, Health IT or mobile medical applications required.
    • Previous experience with cloud-based software preferred.
    • Knowledge of CAD/CAM and AI/ML a plus.

    Knowledge, Skills, and Abilities:

    • Advance knowledge with development and test requirements with recognized standards (ISO
    • Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the Prismatik practices and the QMS.
    • Demonstrated knowledge and understanding of software development, including cloud computing.
    • Demonstrated ability to implement and improve Software QMS processes.
    • Demonstrate knowledge of group software development methods (Agile Process and Scrum Method).
  • PRISMATIK DENTALCRAFT, INC.

    Quality Assurance Engineering Manager

    5 hours ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Position at Prismatik Dentalcraft, a subsidiary of Glidewell · Essential Functions: · Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects. · Hires, manages, trains, develo ...

  • Glidewell

    Sr. Quality Assurance Engineer

    4 weeks ago

    Glidewell Irvine, United States

    Description · Position at Prismatik Essential Functions : · Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medic ...

  • PRISMATIK DENTALCRAFT, INC.

    Senior Quality Assurance Engineer

    3 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Prismatik Dentalcraft is a Glidewell Dental company. · Essential Functions: · Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal an ...

  • Prismatik

    Manager - Quality Assurance Engineering

    3 weeks ago

    Prismatik Irvine, United States

    · Position at Prismatik · Essential Functions: Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects. · Hires, manages, trains, develops, reviews, and set goals for depar ...

  • Motion Recruitment Partners, LLC

    DOD Assurance Engineer

    3 weeks ago

    Motion Recruitment Partners, LLC Irvine, United States

    An international medical device company is looking to bring on a Product Security Engineer to join their team. You'll work on embedded hardware of medical devices, hardening them. Ideal candidates have familiarity with NIST RMF SP process and have used tools like OpenSCAP and DIS ...

  • Network Optix

    Quality Assurance Engineer

    2 weeks ago

    Network Optix Irvine, United States

    Network Optix · (Nx) is a powerhouse in video software development, driven by a mission to empower the creation of intelligent video-based solutions and products capable of converting video into actionable data. Over a decade in the making, the Network Optix Enterprise Video Pla ...

  • Verizon Communications Inc

    Quality Assurance Engineer

    2 weeks ago

    Verizon Communications Inc Irvine, United States

    When you join Verizon · Verizon is one of the world's leading providers of technology and communications services, transforming the way we connect around the world. We're a human network that reaches across the globe and works behind the scenes. We anticipate, lead, and believe ...

  • Motion Recruitment

    DOD Assurance Engineer

    2 days ago

    Motion Recruitment Irvine, United States CONTRACT

    An international medical device company is looking to bring on a Product Security Engineer to join their team. You'll work on embedded hardware of medical devices, hardening them. Ideal candidates have familiarity with NIST RMF SP process and have used tools like OpenSCAP and DIS ...

  • CoStar Realty Information, Inc.

    - Team Lead, Software Quality Assurance Engineer

    2 days ago

    CoStar Realty Information, Inc. Irvine, United States

    - Team Lead, Software Quality Assurance Engineer · Job Description · CoStar Group (NASDAQ: CSGP) is a leading global provider of commercial and residential real estate information, analytics, and online marketplaces. Included in the S&P 500 Index and the NASDAQ 100, CoStar Group ...

  • Kerr Corporation

    Design Assurance Engineer

    4 weeks ago

    Kerr Corporation Orange, United States Full time

    Description · : The Design Assurance Engineer is responsible for developing and maintaining test methods, validations, and verification activities for new product development, sustaining, and quality system compliance activities for dental consumables. · Note: This role will be ...

  • PRISMATIK DENTALCRAFT, INC.

    Quality Assurance Engineering Manager

    4 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Position at Prismatik Dentalcraft, a subsidiary of Glidewell · Essential Functions: · Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects. · Hires, manages, trains, dev ...

  • ACE Partners

    Software Quality Assurance Engineer

    2 weeks ago

    ACE Partners Irvine, United States

    A leading medical device organization are seeking a skilled Quality Assurance Software Engineer to join their team on a W2 contract basis. · Duration: 6-9 Months (opportunity to convert FT after this period) · Rate: $ ph DOE (W2). No C2C or 1099 · Location: Irvine, CA (Onsite) · ...

  • ACE Partners

    Software Quality Assurance Engineer

    1 week ago

    ACE Partners Irvine, United States

    A leading medical device organization are seeking a skilled Quality Assurance Software Engineer to join their team on a W2 contract basis. · Duration: 6-9 Months (opportunity to convert FT after this period) · Rate: $ ph DOE (W2). No C2C or 1099 · Location: Irvine, CA (Onsite) ...

  • PRISMATIK DENTALCRAFT, INC.

    Quality Assurance Engineering Manager

    3 weeks ago

    PRISMATIK DENTALCRAFT, INC. Irvine, United States

    Position at Prismatik Dentalcraft, a subsidiary of Glidewell · Essential Functions : · Ensures products meet customer requirements and complies with US and international regulations. Manages new product development and process improvement projects. · Hires, manages, trains, deve ...

  • Financial Statement Services, Inc

    Software Quality Assurance Engineer

    2 days ago

    Financial Statement Services, Inc Santa Ana, United States

    Job Description · Job DescriptionOpening its doors over 40 years ago, FSSI is one of the largest woman-owned providers of document services in the western United States, specializing in highly-customizable print and mail, electronic delivery, marketing and compliance solutions. A ...

  • enVista

    Design Assurance Engineer

    10 hours ago

    enVista Orange, United States

    Job Description: · The Design Assurance Engineer is responsible for developing and maintaining test methods, validations, and verification activities for new product development, sustaining, and quality system compliance activities for dental consumables. · Note: This role will ...

  • BioPhase Solutions

    Sr. Quality Assurance Engineer

    2 weeks ago

    BioPhase Solutions Orange County, United States

    Job Description · Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Sr. Quality Assurance Engineer to work for an Orange County area medical device company.Salary: ...

  • Pacific Life

    Quality Assurance Engineer

    3 weeks ago

    Pacific Life Newport Beach, United States

    Job Description · Join us as a trailblazing Quality Assurance (QA) Automation Engineer in the Workforce Benefits Insurance domain, where your expertise will be the driving force behind our mission to revolutionize the insurance landscape through cutting-edge digital solutions. A ...

  • Insight Global

    Process Quality Assurance Engineer

    3 weeks ago

    Insight Global Cypress, United States

    A company is seeking a Process Quality Assurance Engineer to join their team The Process Quality Assurance Engineer will be responsible for ensuring the integrity and quality of processes from inception to completion. This role involves a strong focus on configuration management, ...

  • Porsche Motorsport North America , Inc.

    Quality Assurance Analysis Engineer

    3 weeks ago

    Porsche Motorsport North America , Inc. Carson, United States

    Position overview · At Porsche, we are driven by dreams. Porsche Engineering Group (PEG) is an international technology services provider to the automotive industry with locations in Germany, the Czech Republic, Italy, Romania, China, and now in the United States. Porsche Enginee ...