Description
A leading contract manufacturer, located east of St. Paul, is in need of several Quality Engineers to support their continued growth.The Quality Engineer will have the following responsibilities:
- Write protocols and implement validation plans.
- Coordinate new process techniques that improve overall job efficiencies
- Implement systems and procedures that assure compliance with quality standards
- Development and implementation of statistical incoming and in-process sampling/control plans
- Manage the qualification of processes performed by PPC suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections
- Participate in project meetings representing quality, as assigned
- Provide engineering team with data from analysis tools as needed
- Maintain effective communication between functions regarding quality matters
- Function as the liaison between the customer and the facility regarding quality matters
- Actively participate in continuous improvement, corrective action planning and customer satisfaction initiatives as assigned
The Quality Engineer must meet the following requirements
- Bachelor degree or equivalent experience
- Minimum of 6 years experience in quality within the medical device industry
- Minimum of 3 years experience in auditing
- Strong understanding of IQ/OQ/PQ
- Experience leading audits
- Experience with sterilization processes of the supplier
- Experience with packaging design requirements
- Strong understanding of ISO 13485 and 21 CFR Part 820
- Excellent communicator
This is an excellent opportunity with a fast growing company. If you are interested please apply now!
To find out more about Real please visit www.realstaffing.com