About the job
As a Quality Engineer at Nextern, you will play a crucial role in managing quality requirements between our organization and key clients. Your primary focus will be to ensure that customer quality expectations are met across engineering, production development, and the supply chain. You will balance responsibilities across various areas to achieve outstanding product quality while adhering to company standards, regulatory requirements, and customer guidelines.
- Lead investigations of complaints and Corrective and Preventive Actions (CAPA).
- Engage in direct communication with both internal and external clients.
- Conduct internal audits to ensure compliance.
- Drive updates to Quality Management System (QMS) documentation.
- Oversee validations and Test Method Validations (TMVs).
- Execute Initial Inspection Reports (IIR) and First Article Inspection Reports (FAIR) independently.
- Support engineering activities including Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs).
- Participate in new product introduction activities, providing support as needed.
- Assist quality functions in product development and transfer processes.
- Mentor team members in investigations and Root Cause Analysis methodologies.
- Provide assistance to various engineering areas with minimal support.
- Act as the Quality leader in development projects.
