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Software Quality Engineer

Insight Global

Software Quality Engineer

Irvine, CA
Full Time
Paid
  • Responsibilities

    Job Description

    An employer is looking for a Software Quality Engineer. The employer is an enterprise level company in the medical device industry and this engineer will be joining their quality group. This Software Quality Assurance Engineer will provide quality software engineering support in design and development of medical device products. They will facilitate the application of software design controls in product development and sustaining changes. Tasks:

    • Ensure software development and V&V processes meet quality and regulatory requirements of FDA and ISO
    • Provide ongoing software quality engineering support throughout the product software life cycle by participating in Software development reviews, code reviews and formal software technical reviews
    • Review new and modified product designs for quality characteristics, testability and traceable to product requirements.
    • Review verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
    • Review Design History Files and Technical Files for conformance to applicable requirements
    • Assist, when appropriate with internal and supplier audits.
    • Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
    • Contribute to software life cycle process improvements
    • Responsible for validating internal Quality System Applications/Tools.
    • Create all required documents for Intended Use Validation of Quality System Tools.

     

     

    Requirements:

    • Bachelor’s degree (in a software related discipline is preferred)
    • 3 years of experience with software quality engineering
    • Coming from a regulated industry (medical device is preferred)
    • Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
    • Understanding of Object-Oriented Programming
    • Proficient in LabVIEW and/or C++ or C#.
    • Experience with analyzing data from SQL databases and writing SQL queries
    • Understand the processes and intent of all aspects of the QMS related to Design Controls
    • In-depth knowledge of and auditing experience to the 21CFR820, ISO 13485, IEC62304 Medical Device Directive and EU Medical Device Regulations
    • Skilled in test plan development and root cause/failure analysis.

    Pluses:

    • Experience in risk evaluation techniques, such as DFMEA & Product Risk Assessment.
    • ASQ CQE, CSQE certification desirable, but not essential.
    • National Instruments TestStand, LabVIEW knowledge and experience highly desirable
    • Experience with Software Reliability