Software Quality Specialist

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Employer: Flex Romania
Domain:
  • Quality Control
  • IT Software
  • Job type: full-time
    Job level: 1 - 5 years of experience
    Location:
  • Timisoara
  • Updated at: 25.04.2017
    Remote work: On-site


    For our local Quality Team in Timisoara, we hiring Software Quality Specialist. This position will be responsible to provide support during software validation projects as needed.
     

    Specifically, you will:

    • Support Software Validation activities (communication with software user/software validation engineer to define intended use requirements);
    • Understand software use functionality, work with standards/regulations pertaining software/computer system validation;
    • Support the development of test cases, advice on test case outcomes, support report writing, and approve reports;
    • Maintain Software Validation inventory; Perform software validation trainings;
    • Write Software Validation Plans, Protocols and Summary Reports as needed;
    • Communicate with corporate software validation team on use and validation of different software;
    • Provide QMS guidance and support to software users and IT department on the change management process for software associated with medical devices; 
    • Provide ongoing support and advice on software related medical device compliance aspects as needed;

    Your needed skills:

    • High University Degree
    • Minimum 2 years’ experience in quality area; Experience in a similar position would be an advantage;
    • Quality standards knowledge ISO 9001, ISO 13485 - would be a plus;
    • Software Development Life Cycle knowledge – basic understanding; Project Management skills;
    • MS Office - Average level (Excel, PowerPoint, Word)
    • English – Advanced level skills
    • Excellent communication and presentation skills; analytical thinking;
    • Proactive attitude, able to work with minimum supervision;
    • Able to prioritize tasks and understand impact of his/her work on the business partners’ activities;
    • Skills in drawing up reports and procedures appropriate to the industry;

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