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