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In this role, you have the opportunity to
Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design
Validates key design inputs like: usability, reliability, performance,
supportability,
serviceability,sustainability and costs
Provides effective oversight of: the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle
You are responsible for
To lead quality related problem solving for software
Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and
initiate field actions when required
Act as a single point of contact (person assigned to project team) responsible
to ensure that software design quality relatedrequirements/criteriaare completed and meet SW Quality standards for every PRP milestone
Make a substantial contribution to ways of combining Agile withmedical softwaredevelopment
To succeed in this role, you should have the following skills and experience
Working knowledge of appropriate global medical device regulations, requirements and standards. consumer product regulations, industry. standards, such as 21 CFR Parts 803, 806 and 820
8-10 years of work experience in a related field
Experience in IEC 62304 and software quality experience mandatory
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Our hybrid working model is defined in 3 ways:
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