|Brooklyn Park, MN|
The primary purpose of this position is to perform measurements of parts in-process involving prescribed measurement tools. This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols. Demonstrate leadership abilities in the absence of the Supervisor or Team Leader.
Key Accountabilities and Responsibilities
1. Adheres to GB Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
2. Uses measuring tools, measuring machines and electronic instruments to perform inspections in accordance with authorized specification and quality control standards.
3. Performs analysis and develops new procedures to make accept/reject decisions.
4. Performs troubleshooting and makes recommendations, as necessary. Develops solutions for routine and non-routine technical problems.
5. Creates programs for automated inspection equipment, performs program verifications, trains inspection and operations on use of equipment and programs.
6. Assists Engineers in the development of new measurement systems and processes, or in new applications of existing processes.
7. Uses judgement and problem-solving skills to provide input in the evolution of measurement equipment, systems and processes.
8. Works in individual and team settings. Trains other Associates on the proper use of measurement equipment and correct procedures.
9. May repair, modify and/or maintain systems and measurement equipment.
10. Prepares necessary documentation and ensures paperwork compliance on all inspected items, including filing, scanning and verification of device history records.
11. Interacts professionally with other departments to provide detailed data, analysis results and decisions.
High School diploma or equivalent. Associate’s Degree in a technical field or other technical degree preferred.
5-7 years of experience in manufacturing or regulated industry.
Ability to read and interpret drawings/prints. Has basic knowledge in the use of hand gages, tool scopes and height stands. Experience measuring physical dimensions on parts. Advanced knowledge of GD&T. Experience with Vision-based CMM systems.
Ability to read and understand work instructions. S