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Supplier Quality Engineer
Mevion Medical Systems, Inc. is a radiation therapy company dedicated to advancing the treatment of cancer. As the pioneering developer of modern proton therapy systems, Mevion provides innovative, safe, and effective solutions by transforming advances in medical technology and science into practical clinical realities.
Mevion's flagship product, the MEVION S250 Proton Therapy System, is designed to preserve all of the treatment benefits of traditional proton treatment systems while removing the obstacles of size, cost and complexity. Realizing this vision, Mevion has forever changed the economics and accessibility of proton therapy and the face of cancer treatment worldwide.
Founded in 2004, Mevion is a closely held private company headquartered in the Boston metropolitan area with international offices in the United Kingdom and Japan.
The MEVION S250 Proton Therapy System is USFDA 510(k) cleared and complies with MDD/CE requirements.
Supplier Quality Engineer
We are an exciting Medical Device company in need of a Supplier Quality Engineer who will help the team move forward in our drive to revolutionize cancer treatment.
Job Duties and Requirements, include:
* Lead in Supplier Quality improvement teams, manage supplier yield/data reporting, and ensure continuous improvement.
* Resolve design, workmanship, material, and process issues affecting product quality and initiate respective corrective actions including the pre- dispositioning of incoming material.
* Support MRB evaluations, development of incoming quality requirements and statistical analysis of incoming and supplier process data.
* Issue and monitor CAPAs and work with suppliers to achieve timely and comprehensive corrective actions.
* Work with suppliers to improve quality, reduce costs, and maintain on-time deliveries.
* Manage the design change process including communication to suppliers, obtaining quotes, coordinating the kitting of needed materials, issuing work orders, and maintaining DHR information.
* Provide support to Supply Chain Sourcing initiatives and product transfers; and Develop validation documentation to support new product development and changes to existing products.
* Perform supplier and internal audits, IAW, ISO 13485, and ISO 9001, and develop corresponding audit reports.
Minimum educational, training and experience qualifications:
* Bachelor’s degree in Engineering plus at least 10 years of progressively more responsible experience in manufacturing and quality.
* Supplier management experience.
* Experience with key supplier controls, including document, change and inventory controls.
* Product development process experience.
* Basic computer knowledge, including Microsoft Office Suite.
* Strong quantitative, analytical and Process Redesign skills.
* Strong aptitude with electronics box build and mechanical assembly.
* Knowledge of cryogenics and vacuum technology, Radiofrequency systems, High power electronics.
* Experience in using Manufacturing tools (Six Sigma, SPC and/or equivalent tools).
* A background in Lean Manufacturing of low production volumes (<100 units/yr.).
* Travel up to 50% as required.
Mevion Medical Systems, Inc. offers competitive compensation and benefits.
Mevion Medical Systems, Inc. is an equal opportunity employer.
For consideration please send resume to email@example.com