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Manufacturing Enigneer

Real Staffing Irvine Full-Time
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Position Responsibilities:

Responsibilities may include the following and other duties may be assigned.

    • Ability to summarize data from variety of sources to draft post market surveillance reports on ongoing basis.
    • Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
    • Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
    • Represent client as appropriate in FDA, notified body, internal, and other audits.
    • Other duties as assigned or required.

Nice to Have: Preferred Qualifications

  • Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and/or guide wires.
  • Extensive knowledge of quality tools:
Risk analysis
Highly proficient in math and use of statistical techniques
Root cause analysis
Problem solving approaches

  • FDA/ISO/MDD/EUMDR requirements and guidance
  • Mastery of relevant software programs preferred - Microsoft Word, PowerPoint, Excel, and Project, and Minitab.

Sthree US is acting as an Employment Business in relation to this vacancy.


Skills required

Sample Procedure
Quality Assurance
Performance Testing
Perform Inspection
Total Quality Management
Provide Technical Guidance
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Job ID: RE-33143882


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Real is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services. We are one of the world’s most extensive pharma, biotech and medical devices recruiters and have one of the largest networks of specialist recruiters globally.

Our premise is a simple one: by recognizing talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time.

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