Document Control Technician

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.

Under the direction of the Document Control Supervisor, the Document Control Technician supports the various Quality Management System (QMS) elements at the facility. 

KEY ROLE AND RESPONSIBILITIES: 

• Review all Device History File Records before release 

• Resolve discrepancies in documentation, counts, parameters, etc. 

• Review labeling and quality documentation and resolve discrepancies 

• Complete product release documentation 

• Accountability for tracking lot status, archive lot files, and certification of all lots 

• New Product Introduction (NPI) Support 

• Assist in Internal and External Audits, as Required 

• Customer Material Inquiry Support  

• Support project and other Quality Assurance activities as assigned 

• Demonstrates all of the Flexan 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: 

• Associate degree or equivalent from two-year college or technical school; or minimum two years related experience and/or training; or equivalent combination of education and experience. 

• MS Office skills 

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  

• Ability to write routine reports and correspondence.  

• Ability to speak effectively before groups of customers or employees of the organization. 

• Ability to add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals.  

• Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. 

• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  

• Ability to deal with problems involving several concrete variables in standardized situation

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.