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 generation 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