The Quality Engineer will build and maintain quality plans for Machined components being contract manufactured throughout the process, including- Milling, pre/post machining operations, and the manufacturing processes. Ensure the effectiveness & improvement of the Quality Management System- QMS and to maintain and build a culture of Quality and Continuous Improvement throughout the organization
- Evaluate manufacturing processes with the goal of continuously improving process performance, machine utilization, and reduction in setup time.
- Understands and communicates regulatory requirements to ensure compliance
- Develops, documents, deploys, maintains various components of the QMS
- Facilitates customer drawing reviews to ensure production readiness and inspect-ability
- Facilitates process development/improvement and related documentation
- Develops and executes process and equipment validation protocols and reports
- Support management of the Non-conforming Material process, including facilitation of root cause analysis, and corrective action implementation
- Facilitates/leads risk management activities
- Performs internal audits in accordance with internal audit schedule
- Participates in customer and regulatory audits as required
- Experience in a machine shop environment with axis mills and screw machines
- SolidWorks and AutoCAD
- Exposure to an ISO certified and/or FDA manufacturing environment
- Strong background in Geometric Dimension and Tolerating(GD&T) preferred
- Exposure to inspection equipment and techniques.
- Experience in CMM/RAM measurement
- Superior communication & interpersonal skills
- Bachelor of Science Degree in Engineering or comparable discipline
- Certifications including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma would be preferred, not required.