Quality Engineer

Job Description
Summary
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Report to the Director of Quality
Focus on LEAN/Six Sigma

About Our Client

Our client is a private equity backed manufacturer located in the Wheeling area. This is a new role for their business and will report to their Director of Quality. They focus on medical and industrial markets and have steadily grown over the last 15 years.

Job Description

Perform duties and responsibilities assigned by Director of Quality
Perform product, process, and change control risk mitigation actions, utilizing: Control Plans, pFMEAs, Flow Diagrams
Risk Assessment Audits, 5S Audits and ISO based Internal Audits
Work Instructions, Process Mapping and Checklists
Provide support for gage calibration program to meet ISO 9001 & ISO 13485 requirements
Create and implement new ISO 9001 and ISO 13485 procedures and work instructions
Provide quality engineering support to all departments.
Performs statistical analysis and write technical reports

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Bachelor's Degree from an accredited college or university
Ability to read and understand blueprints, including GD&T
Experience working in an environment certified to ISO 9001:2015, ISO 13485:2016 and CGMP Good Manufacturing Practices
Experience with Lean / Six Sigma Problem Solving tools
Ability to work with mathematical concepts such as probability and statistical analysis
Good understanding of SPC and Gage R&R including conducting studies and reporting results