Sr. Quality Assurance Engineer, Medical Device
Real - Redwood City, CA

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Duties include:
  • Design History Files transfer and maintenance, remediation to company requirements and maintenance for these products, including preparation of the Lifecycle Management Systems requirements.
  • Design transfer, including product/process validations.
  • Support improvements to processes at current Contract Manufacturer pending transfer to the site.
  • Emphasis on detecting design defects / process issues to minimize the impact to cost and schedule, and enable the implementation of appropriate controls/ specifications.
  • Review, approve, and manage documents, e.g. validation protocols, SOP's, specifications for accuracy and completeness; generate/revise documents as needed.
  • Utilize best practices for experimental design, fundamentals of statistical process control, sampling rationale, and reliability assurance.
  • Participate in continuous improvement initiatives such as QLP, BioScience Operating Systems, Lean and Six Sigma.
  • Track and trend department metrics and quality indicators.
  • Quality assurance engineering experience of technology transfer.
  • General working knowledge in continuous improvement tools is preferred.
  • Strong working knowledge in project management tools and methodology.
  • Experience in the area of design input/output review, design validation, design transfer, and Design History Files creation and management within medical devices is preferred.
Joining this fast-paced and cutting-edge company will allows you to work with the best in the field. This company is offering a competitive rate for this contract to hire role. Please be in contact as soon as possible.
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Real - 2 years ago - save job
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