A Quality Engineer is needed for an American multinational personal care corporation in the Neenah, WI area. Ensure compliance to quality procedures / processes. Conduct product quality tests, compliance and process audits. Evaluate quality performance. Investigate quality issues and implement corrective actions.
Expert position that requires a Bachelors or Masters degree and 5-10 years of experience.
location: Neenah, Wisconsin
job type: Contract
salary: $33.00 - 48.38 per hour
work hours: 8am to 5pm
- In support of test method 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 TMV team under the leadership and guidance of trained team members.
- In support of Quality system improvement initiatives - 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
- In support of tampon capacity expansion programs (projects Naplex 4 and Tomorrowland 2.0)
- 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
- This work would be under the supervision of an internal class 2 medical device developer
- 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)
- Experience level: Experienced
- Minimum 10 years of experience
- Education: Bachelors
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.