Rochester, NH
Date Posted: November 08, 2016
Employment Type: Contract To Hire
Job Id: 7248

Job Description

Quality Engineer


  • 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
  • Supplier Quality evaluation, monitoring, and improvement.
  • Review and approve validation activities.
  • Support Design and Design Transfer activities as needed.
  • Sterilizations for both ETO and Gamma Radiation in accordance with the appropriate standards.
  • Ensure adequacy and compliance of Environmentally Controlled Areas.
  • Provide support for and perform Document Control activities as needed.
  • 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.
  • Conduct investigations for equipment failing calibration.
  • Complete, review and approve fixture files as necessary
  • Assist in maintaining traceability of products.
  • All other duties as assigned.


Required Skills, Knowledge and Expertise2

  • Working knowledge of ISO13485, ISO 9001, FDA CFR Part 820, Medical Device Directives
  • Medical Device Directives and product – specific applicable standards
  • FDA Quality System Regulations
  • Canadian Medical Device Regulations
  • EtO sterilization
  • Gamma Sterilization
  • Statistics
  • Quality Management Tools
  • Problem Solving
  • Root Cause Analysis
  • Supplier Performance
  • Project Management
  • Advanced Product Quality Planning (APQP)
  • Proficient in Microsoft Office Software suite

Desirable Qualifications:

  • Scientific education (biological sciences or other technical)
  • Quality Certifications (ASQ or other)
  • 2-5 years Quality/Regulatory experience in medical device manufacturing

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