Quality Engineer

About the Job Portal Diabetes, Inc. has an exciting career opportunity for an experienced Quality Engineer. In this broad role you will be you will participate in the both the design control and manufacturing quality control for the product. The Company Our goal is to deliver a next implantable automated Insulin delivery pump that significantly improves the quality of life for users with Type 1 Diabetes. We are a small, fast paced company located in Westfield, Indiana. Job Responsibilities Works with Product Development and Operations teams to establish quality requirements at all phases of product/process development and manufacturing Applies regulatory requirements such QSR, MDR, ISO and participates in development and maintenance of procedures in compliance with regulations Works with Product Development on product V&V activities including review of protocols and reports Work with Product Development on the Risk Management Process and maintains the Risk Management File Technical support for Incoming Inspection including First Article Inspection Responsible for Supplier Management activities including qualifying suppliers, maintaining the Approved Suppliers List (ASL) and associated files, and managing Supplier Corrective Action Technical support for the Non-Conforming Material system, including review of dispositions and associated actions Assists with internal and external audits Reports directly to the COO Required Skills/Experience BS degree in Engineering or Chemistry related discipline Minimum 5 years experience in a Quality role in the medical device, aerospace or automotive industries Self-starter, well organized Good written and verbal communication skills Ability to self-start, work independently and collaboratively in a small team environment Desirable Skills/Experience Medical Device manufacturing experience highly desirable Proficiency with statistical analysis is a plus