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Engineering


Quality Engineer  Pawtucket, RI  Posted: 1/8/2019
Job Description

Job Number:

225

Category:

Engineering

Pay Range:

70,000.00 - 90,000.00

Shift:

2nd


Details:

Quality Engineer - Medical Device - 2nd Shift
  • Quality Engineer medical device industry experience
  • Strong knowledge in design and development of medical device products
  • Experience in Quality System tools and problem solving
  • ISO 13485 and QSR/cGMP requirements
  • Action plan development and root cause analysis completion of CAPA activities.
  • Write and review quality documentation such as procedures, test protocols and reports.
  • Coordinate efforts with department leads for the development and implementation of new and updated Quality System procedures and processes.
  • Work with department leads in identifying and establishing quality related metrics.
  • Apply root cause analysis and problem-solving methods in identifying, prioritizing, communicating, and resolving quality related issues.
  • Investigation and processing of product investigations for nonconforming materials
  • Development and optimization of current quality processes
  • Assist in the development of process monitoring and measurement tools.
  • Provide support with Internal & External audit activities.
  • IQ, OQ, PQ and Validations to support ISO 13485 requirements 
 Supplier Qualification, Product Inspection, CAPA, Validation, Management Review and aiding R&D and Manufacturing with product complaints and investigations.
  • BS ME/MFG/QE
  • 3+ years of experience
  • Medical Device 
 
Send resume to: 
Search Staffing Group, Inc./Engineering Group

 
Job Requirements



 

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