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Quality Engineer

  • Location: Neenah, WI, 54956
  • Job Type:Contract

Posted 4 months ago

Job Title: Quality Engineer

Term: 12 months 

Location: Neenah, WI (Remote to start, then onsite when office reopens)

We are looking for a Quality Engineer to join our team for a 12 month contract. 

Responsibilities:

  • Ensure compliance to quality procedures / processes.
  • Conduct product quality tests, compliance and process audits.
  • Evaluate quality performance.
  • Investigate quality issues and implement corrective actions.

Requirements:

  • Must have Medical Devices regulatory Class 2 or Class 3 experience.
  • Validation remediation and retrospective reviews (Class 2 medical devices)
  • Need Knowledge in Design controls and change controls for FDA regulated medical devices
  • IQs, test method characterization, test method validations
  • Incremental support to our internal team under the leadership and guidance of trained team members.
  • Remediation of quality system documentation, design documentation, DHFs, DTMs, RTMs, etc.
  • Need a team member with strong technical skills and attention to details
  • Experience in ETQ as a quality system preferred
  • Support of change control, document control and design controls for development and installation of known equipment
  • Potential support of IQ/OQ/PQ – documentation and/or onsite support ·
  • Quality system KPI and metric support
  • Medical device (FDA Class II) engineering development project support
  • QMR presentation slide preparation
  • CAPA Investigation and Effectiveness support
  • Procedure, Work Instruction and quality system documentation
  • DOORS database setup support (Excel documentation / setup)
Apply to MATRIX today!