NextPhase Medical Devices LLC is a fast growing, contract manufacturer of single use and electromechanical medical devices, with facilities in Rochester, NH, Mansfield, MA, Waldwick, NJ and Tijuana, Mexico.
Based in our Rochester, NH facility, the Quality Engineer supports the Quality Management System (QMS) to ensure compliance to the regulatory and procedural requirements in the manufacture of single use disposable medical products for NextPhase’s customers. The Quality Engineer will assist the assigned Value Stream Business Unit in the establishment and implementation of programs designed to assure control of processes and products toward the established standards of quality under NextPhase’s QMS.
- Act as the NextPhase quality function interface for assigned customers and suppliers.
- Monitor customer complaints and trend. Respond as needed to failure investigations and corrective actions.
- Guide and support the Value Stream to address product/process issues including NCMR's, MRB, root cause analysis, deviations, test procedures and protocols.
- Design, create and test document measurement and assebly fixtures.
- Conduct risk analysis for products and processes being transfered, following guidance under ISO 14971.
- Drive the CAPA process to completion on assigned corrective and preventative actions.
- Develop verification and validation protocols supporting the implementation of products and processes into NextPhase’s clean room production environment.
- Support audits performed by our Notified Body and customers. Perform and participate in audits of suppliers as required.
Skills & Experience Required:
- Bachelor of Science degree in Engineering, Biology or related discipline
- 2-5 years of related Quality Engineer experience in a medical device manufacturing
- Certificate in CQE and/or CQA preferred
- Experience conducting Root Cause Analysis using Fishbone Diagrams and/or Fault Tree Analysis
- Experience working with and understanding of ISO 14971 Risk and Hazard Assessment
- Experience using Microsoft Office, including Word, Excel, PowerPoint and Outlook