- Location
- Maple Grove, Minnesota, United States · published
- Type
- Full-time
- Department
- IT
- Source
- Workable
Description
At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.
This position is responsible for ensuring production and process control compliance during the development and manufacturing of medical devices at the Nextern Maple Grove facility. This position may also involve quality assurance of product conformance for dimensional, electrical, and visual workmanship standards in accordance with requirements.
2nd shift - Monday through Thursday - 3:30PM to 2:00AM
RESPONSIBILITIES
- Responsible for ensuring production and process control compliance during the development and manufacturing of medical devices. Including, but not limited to, direct monitoring and correction/training of production staff.
- Perform comprehensive manufacturing Device History Record (DHR) review at close of manufacturing process and product release.
- Makes decisions on how to handle product issues with the operator accordingly and matters pertaining to whether or not product is acceptable.
- Identifies and evaluates procedures to ensure the production of quality product during manufacturing.
- Provides the Quality group with technical support as required.
- May write technical reports and other required quality documentation.
- Demonstrates safe work habits, maintains clean and safe work area.