Software Quality Manager
Company: FPC of Raleigh
Location: New Haven
Posted on: March 21, 2020
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Job Description:
Excellent opportunity to join a dynamic Medical Device company
as a Software Quality Manager (embedded) with a strong career path
for growth and development. You will work on multiple projects and
lead initiatives as well as support new product development. The
Software Quality Mgr will:ESSENTIAL
FUNCTIONS:----------------Support the development and manufacturing
of medical devices in conformance with the Quality System
Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC
62304 and other regulatory standards.----------------Ensure
internal Design Control policies and procedures comply with
regulations and external standards, including software regulations,
risk management, and change control----------------Contribute to
the streamlining and continuous improvement of the software
development and maintenance process to ensure robust and efficient
development and launch of new and innovative healthcare
products----------------Provide guidance for the application of
internal development procedures, including Design Control, to the
product development teams, within the framework of regulatory
requirements.Must Have: Minimum RequirementsBachelor's Degree in
Engineering, Science or technical field with 5+ years of work
experience in Engineering and/or QualityOR Advanced Degree in
Engineering, Science or technical field with 3+ years of work
experience in Engineering and/or Quality.Experience with imbedded
SW in a Medical Device environment mandatoryCompetitive salary and
benefits as well as relo assistance is offered.
Keywords: FPC of Raleigh, New Haven , Software Quality Manager, IT / Software / Systems , New Haven, Connecticut
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