Description
A leading medical device company, located on the border of Minnesota and Wisconsin, is in need of several Quality Engineers to support their rapid growth.The Quality Engineer will have the following responsibilites:
- Act as a technical resource and fully support GNE Registration, launch and sustaining production
- Coordinate new process techniques that improve overall job efficiencies
- Implement improvements and processes compliant with ISO 13485, 21CFR820, 21CFR Part 210 and 211
- Development and implementation of statistical incoming and in-process sampling/control plans
- Troubleshoot and lead corrective actions relating to performance
- Improve process for supplier data submission to reduce internal inspections
- Participate in weekly meetings representing quality, where appropriate
- Provide engineering team with information and analysis tools as needed
- Facilitate communication between engineering function, manufacturing, and quality
- Responsible for being a communication liaison between the customer and manufacturing facility and enhance customer satisfaction
- Measure validated process effectiveness and lead continual improvement of system
- Communicate and coordinate all quality activities for product line including internal and external approvals
- Travel may be required to facilities, customers or suppliers to support business needs
The Quality Engineer must meet the following requirements:
- B.S. Engineering or a related field
- Minimum of 7 years experience within Quality in the Medical Device industry
- Strong understanding of ISO 13485
- Experience in auditing
- Excellent communicator
This is a 6 month contract and likely to become full time. Please apply now if interested.
To find out more about Real please visit www.realstaffing.com