Come join an amazing team! If you are a Quality Engineer with a Bachelors in Engineering or related field consider discussing this opportunity with us.

You will be responsible for the following:

Perform duties and responsibilities assigned by Director of Quality

Perform product, process, and change control risk mitigation actions, utilizing: Control Plans, ppaps, 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

Bachelor's Degree/ Engineering or related field 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