Design Transfer Manager - San Carlos, CA

Only for registered members San Carlos, CA, United States

1 month ago

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We are seeking an experienced Design Transfer Manager to lead and coordinate the transfer of an early cancer detection assay from R&D into Operations.

The role will plan execute implement and document all design transfer activities for a next generation sequencing NGS IVD/PMA assay under Quality Systems Regulations and Design Control.

PRIMARY RESPONSIBILITIES:
  • Responsible for planning managing activities studies from late-stage development to launch
  • Contribute to design documents such as reagent stability plans design inputs outputs verification protocols reports while working closely with Quality Regulatory partners
  • Routinely participate in risk management activities such as hazard analysis FMEA to identify hazards causes propose controls mitigate risks

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