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Software Quality Engineer

Intellectt INC

Software Quality Engineer

Thousand Oaks, CA
Full Time
Paid
  • Responsibilities

    Job Description

    Hi

    We have an immediate requirement for Software Quality Engineer. If you are looking for new job roles, please share your updated resume or you can reach me on +1 732 338 7842

    SOFTWARE QUALITY ENGINEER

    REMOTE LOCATION: THOUSAND OAKS, CA

    1. START TO FINISH EXPERIENCE WITH DIGITAL DEVICES, HEALTH TECHNOLOGY, PRODUCTS, MOBILE MEDICAL APPS,

    2. DEEP EXPERIENCE WITH SOFTWARE MEDICAL DEVICE QUALITY AND COMPLIANCE CONCEPTS

    3. STRONG PROJECT MANAGEMENT SKILLS / ABILITY TO LEAD AND/OR LEAD ALL ASPECTS OF NUMEROUS PROJECTS SIMULTANEOUSLY

    Accountable to ensure quality and compliance associated with Amgen software medical devices, to develop, maintain, and continuously improve the software medical device and digital health product quality capability, to ensure compliance with procedures and regulatory expectations for existing and new software medical device and digital health product programs, and to develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches.

    KEY RESPONSIBILITIES:

    Benchmark with industry regarding quality and compliance models for software medical devices and digital health products

    Accommodate Agile software development methodology

    Ensure inspection readiness and maintain CE marks for existing software medical devices

    Train and mentor relevant staff for development and succession planning

    Maintain and resource program and project quality support portfolio

    Collaborate with Senior Management, data management and presentation, provide backup support to other Quality focus areas

    Work in partnership with the DH & DQ Leadership to develop business plans that cultivate staff development and supports the direction of the business

    Plan and lead all aspects of major change efforts in the digital health space

    Authority

    Assure that current regulatory trends are accommodated in the capability

    Advise software medical device and digital health product teams as Quality representative

    Review and approve medical device design control and post-commercial documentation (internally and at times, externally)

    Interface with regulators and Notified Bodies

    Review and approve procedures and work instructions