Flexan is a global strategic contract manufacturer of custom high-quality silicone and thermoplastic components, sub-assemblies and devices designed to meet the critical requirements of Class I, Class II and Class III medical devices, as well as custom compounding and molding for precision parts.

　　The Quality Engineer is responsible for the full range of QA/RA system support from development activities through managing the handoff of qualified processes to production and ensuring that commercialization activities are successful.  This position is responsible for the proper documentation, reporting, and data analysis as it relates to quality reporting, medical device validation, and customer quality correspondence.   

　　KEY ROLE AND RESPONSIBILITIES: 

　　Tooling technicians provide the following:

　　Production troubleshooting

　　Help set up production machines

　　Technical eyes on production

　　Track tooling inventory for production

　　Order tooling for production

　　IQOQ and implement new tooling for production

　　Assist engineers with new product or CIP projects.

　　Help engineers run engineering lots.

　　Demonstrates all of Flexan’s corporate values: 

　　We have an engaged culture

　　We embrace the rigor to be safety and quality driven in all we do

　　We embrace the choice to work here 

　　We operate with transparency, ethics, and integrity 

　　We consistently meet our expectations 

　　Minimum Qualifications:

　　Experience in quality environment, medical device experience preferred.  

　　Thorough understanding of ISO 9001 Standards and Requirements. Minimum one year of experience with ISO9001 quality management system in a manufacturing environment.  

　　Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software).  SOLIDWORKS or CAD modeling software is a plus ​​​​​​

　　Must be detail oriented, customer service oriented, focused and able to produce accurate and professional documents  

　　It is the policy of Flexan, LLC to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Flexan will provide reasonable accommodations for qualified individuals with disabilities. 

　　Powered by JazzHR