QA Specialist *( 3 - 5 yrs of medical device industry with FDA validat

QA Specialist with Managerial experience (** Must have 3 to 5 years working in a medical device industry with FDA validation.) *w2 6+ month contract

Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).maple Grove, MN 6+

The ideal candidate will possess the following qualifications:

• - At least 10 years working in QA expense, QA or validation management, with some managerial experience
• - Have worked on several large initiatives (more than 1 million budget)
• - Have at least 7 years of writing test cases in Quality Center and managing the testing and defects.
• - Ability to ensure proper test coverage from requirements
• - 3 to 5 years working in a medical device industry with FDA validation.
• - Ability to think on their feet, as well as ability to quickly take on issues
• - Knowledge of EPIQ reliance a plus
• - Ability to take direction or criticism if it is warranted
• - Be able to hit the ground running - there won't be much time for Mani to hand off
• - Needs to be a good communicator and team player
• - Of course a good personality helps, but more important if they are a good resource Additionally, candidates will also need:
• - Experience adding requirements to QC and appropriate linkage to test cases
• - Experience testing mobile applications
• - Ability to understand complex logic and apply appropriate testing
• - Write test cases based on risk level of requirements
• - Experience writing security role test cases Ability to apply comp
• - any standards and best practices, while also identifying areas for improvement
• - Developing a test plan for each software release cycle
• - Experience authoring test cases
• - 7+ years of writing cases in quality center, writing defects, testing management
• - Experience with FDA experience
• - Need someone that can hit the ground running
• - Strong communicator, Not afraid to ask questions, team player
• - Candidates need to be comfortable with waterfall
• - BA is required

Top skills:

• - Medical device experience - software validation
• - Ability to develop a test plan from beginning to end
• - Someone that shows that they can work collaboratively

BS degree or 3-7 years equivalent experience

Saroj Ghosh, Sr. Technical Recruiter,

Direct:

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