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Responsible for working with cross-functional representatives with the Enterprise Healthcare Technology team to implement or update where necessary the Quality Management System (QMS) to support Software as a Medical Devices The candidate will perform a gap assessment against current QMS processes, ...

Job Description

Responsible for working with cross-functional representatives with the Enterprise Healthcare Technology team to implement or update where necessary the Quality Management System (QMS) to support Software as a Medical Devices The candidate will perform a gap assessment against current QMS processes, Enterprise Healthcare Technology strategies, and applicable regulations (e.g., ISO and FDA), and will implement mitigations to identified gaps. The candidate must have working Quality experience supporting and implementing/improving a QMS that complies with ISO 13485:2016 and FDA Quality System Regulations requirements. Experience with SaMD development and Quality oversight is required. Strong communication and interpersonal skills are required. Self-motivation and the ability to work with limited supervision are essential. The ability to write process/procedure documents to support a highly regulated environment is required. 

Implementation of a documented QMS to support Software as a Medical Devices. Write procedural documents to support SaMD. Create training material to support implementation of SaMD process (desirable, time-permitting

Required

  • Self-motivation and the ability to work with limited supervision are essential.
  • Must have working Quality experience supporting and implementing/improving a QMS that complies with ISO 13485:2016 and FDA Quality System Regulations requirements.
  • Experience with SaMD development and Quality oversight is required. Strong communication and interpersonal skills are required.
  • The ability to write process/procedure documents to support a highly regulated environment is required.