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Supplier Quality Engineer
Medical Device/Manufacturing/FDA
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Location: Plainview, NY
Pay Rate: Contract: 36.06 to 43.27 $/hr
Salary: 75.00 to 90.00 K$/yr
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Position Type/ Job Duration: Direct hire
Education Required: BS Engineering/Technical 
Years Experience Required: 7

Industry:
Mfg
Job Posted: 10/22/2017
Should I worry about this date?
Apply Deadline: 11/01/2017
Job #: 134489CJR
Job order status: Client is actively seeking candidates
Relocation available: Not Available


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Supplier Quality Engineer opportunity with a well established medical manufacturing client in the Long Island, NY area. This position will be responsible for all aspects of supplier quality to ensure regulatory compliance. Local candidates preferred although some relocation assistance may be considered on a case by case basis.

Responsibilities

  • Perform regular supplier audits to ensure regulatory compliance
  • Monitor and improve supplier quality and process performance
  • Facilitate and perform on-site visits for root cause analysis and implement and verify corrective actions of supplier quality issues
  • Develop new approaches to solve problems identified during quality assurance activities and assist or lead activities/projects to improve the Quality Management System including coordinating, development, training and maintenance
  • Review customer complaints, conduct product investigations, and ensure proper complaint closure
  • Conduct medical device reporting assessments and process potential MDR reports
  • Other duties as needed

Requirements

  • Bachelors degree in Engineering preferred (will consider non-degreed candidates with applicable experience)
  • Approximately 5 or more years in manufacturing industry in Quality functions in an FDA regulated industry
  • Medical device industry experience is highly desirable (might consider similar FDA regulated industries)
  • Working knowledge of FDA regulations, cGMP, US-FDA’s 21 cfr part 820
  • Demonstrated Supplier Management experience

Benefits

  • Comprehensive Benefits Package, including 401(k)
 
 
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