Rochester, NH
Date Posted: September 08, 2017
Employment Type: Contract To Hire
Job Id: 7877

Job Description

Quality Engineer

 

Responsibilities:

  • Monitoring and improvement of product quality.
  • Defect, scrap and rework prevention.
  • Continuous improvement of and adherence to Quality Management System.
  • Control, document, evaluate and disposition nonconforming materials.
  • Coordinate and monitor inspection activities.
  • Investigate, document and communicate customer complaints. Notify QM if event is reportable per Medical Device Vigilance Reporting standards and requirements
  • Coordinate and perform Corrective Action and Preventive Action activities as required.
  • Internal auditing as required.
  • Provide guidance on regulatory requirements.
  • Perform and/or prepare installation, operational, and performance qualification of equipment as needed.
  • Provide product specifications and task specific instructions for use by Assembly and Quality,
  • personnel and when required specifying the type of inspection or measuring equipment to be utilized.

 

Required Skills, Knowledge and Expertise'

  • Sr QE expected to be skilled in/very knowledgeable of below
  • QE 2 expected to have basic understanding of I able to practice below
  • QE 1 expected to be familiar with and learning below
  • ISO 9001 and 13485
  • Medical Device Directives and product – specific applicable standards
  •  FDA Quality System Regulations
  • Canadian Medical Device Regulations
  • EtO sterilization
  • Gamma Sterilization

 

Education, Certification and Experience

  • BS in Engineering, Biology or related science preferred
  • Quality and/or Regulatory experience in Medical Device manufacturing preferred,
  • ASQ CQE certification preferred

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