The Medical Device Quality Inspection group is responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing, and packaging meet current GMP standards and comply with applicable procedures and standards such as to ensure the quality integrity of the product.
Primary Responsibilities
The Medical Device Quality Inspector inspects parts to specifications that are on a part drawing.
Perform part inspections using measurement tools such as calipers, micrometers, gage pins, plug gages, and thread gages
This person would also be trained to an ERP system; SAP to enter in acceptance data.
Use of another system related to nonconforming material reports to enter failure data.
Material inspection experience as described and be able to work with computer-based applications.
Follow procedures to adhere to industry and regulatory standards.
Team collaboration in supporting production, which means being flexible on assignments
Work overtime is desired as needed, to support production schedules and incoming part volumes.
Required and preferred qualifications
High School diploma. College Degree preferred
Good written and verbal communication skills. Basic math skills
Ability to use measurement devices such as calipers, thread gauges and micrometers to check whether materials or products meet standards
Familiar with ISO13485 or ISO 9001 desired
Experience with optical measurement machines or a CMM desired
Attention to detail with ability to identify defects and flaws
Ability to work in a fast-paced team environment with minimal supervision