Previous Job
Previous
Quality Engineer III
Ref No.: 18-09721
Location: Raritan, New Jersey
Quality Specialist/Quality Manager
Work Site Location: Raritan, Spring House, Titusville or Malvern​
6+ Month Contract


Job Description:
This person will be responsible for working with cross-functional representatives within and 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.

Linked to specific deliverables:
Implementation of a documented QMS to support Software as a Medical Devices within Client. Write procedural documents to support SaMD . Create training material to support implementation of SaMD process (desirable, time-permitting).

Required Skillset:
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.