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Software Quality Manager

Company: FPC of Raleigh
Location: New Haven
Posted on: March 21, 2020

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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