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 Control Technician measures silicone rubber implantable medical device components using defined sampling plans to ensure manufactured product meets customer specifications.

KEY ROLE AND RESPONSIBILITIES

• Establish proper measurement methods, fixturing, and tool requirements in a timely manner.
• Write component specific programs for relevant equipment for automation.
• Review prints for measurement feasibility.
• Perform First Article Inspection(FAI) on silicone components
• Perform Incoming inspection on stainless steel, plastic, and silicone components.
• Perform outgoing product release successfully and independently.
• Perform and document cleanroom environmental monitoring.
• Perform device history record review
• Characterization inspection of components using Nikon iNexiv machine, MicroVu machine, and various gages for engineering and/or special projects.
• Cooperate with and demonstrate professional conduct with coworkers and managers.
• Meet Flexan standards for quality and productivity.
• Complete various required paperwork and documentation error free.
• Follow all procedures for cleanroom operation, cleanroom attire, and contamination control.
• Follow all Flexan procedures for traceability, line clearance, process control, safety, and housekeeping.
• Prevent damage or loss to parts, tools, fixtures, and equipment.
• Accurately input data into ERP system daily (including clock in time, work orders worked on, operation worked on, indirect work performed, quantities of parts produced and quantities of parts that are deviated).
• Other duties as assigned

• Demonstrates all of the 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

• HS Diploma/GED
• 5 years of experience in a Metrology role.
• Basic GD&T knowledge
• CMM/Vision System experience.
• Able to fill out required documents and labels in English
• Able to read and understand process documents and work instructions in English
• Good hand dexterity and fine hand manipulation skill; physically able to perform pinch grasp and repetitive motions.
• Able to sit or stand for extended periods.
• Must have adequate visual skills to perform inspection of parts with a microscope.

SHIFT

• Monday-Thursday 3:30pm-2:00am

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.