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Quality Engineer III
Ref No.: 18-03491
Location: Raritan, New Jersey
Start Date / End Date: 06/01/2018 to 12/31/2018
Description:
Quality Specialist/Quality Manager

Job Description:
This person will be responsible for working with cross-functional representatives within Janssen 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 within Janssen. 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 Janssen. Write procedural documents to support SaMD in Janssen. 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.

Work Site Location: Raritan, Spring House, Titusville or Malvern
Hours per Day 8
Hours per Week 40
Total Hours 1,216.00