Quality Control/Quality Assurance Technician

About the role

We are looking to hire a Quality Control/Quality Assurance Technician immediately for a contract-to-hire position based in Allen, TX. This is a fully onsite role.

Responsibilities

• Inspect incoming raw materials pertaining to Disposables
• Inspect and test in-transfer products
• Document all non-conformances when necessary
• Understand, follow, and practice the rules/regulations set forth by the QSR, ISO 13485, and the company's internal guidelines
• Review processes to assure procedural compliance and recommend improvements
• Perform and review visual, dimensional, and functional inspection of incoming raw materials pertaining to Disposables and Electronics
• Identify key inspection points and the proper tools/equipment to ascertain these points
• Perform inspections and verification of finished products
• Review inspection data and DHRs (including sterilization records) for accuracy and compliance to the applicable standards
• Perform inspections and process Returned Goods/Materials (RGAs/RMAs)
• Use recognized sampling plans to determine statistical size of samples
• Perform and review tests according to various GMP protocol requirements
• Document and review inspection results per GMP/GDP
• Generate non-conforming material reports (NCMR) for products that do not conform to test specifications and contact the appropriate personnel
• Communicate needs of department/company to management
• Assist engineering staff with process improvement projects regarding improved quality inspection of product and components (such as First Article Inspections and qualification testing)
• Work in all QA areas (IQC, Finals, and Electronics) if needed
• Execute and maintain 5S environment

Requirements

• High School graduate or equivalent work-related experiences with previous quality control experience desired (minimum of 5 years)
• Strong dimensional inspection using caliper, micrometer, snap gage, torque, vision system including optical comparator, OGP Smart system, and other inspection and measurement tools
• Detail oriented, computer literate, and possesses a professional demeanor
• Adaptable to changing environments and capable of completing tasks with little or no supervision
• Computer skills including MS Excel and MS Access (basic knowledge of each)
• Good written and oral communication skills required; must be able to read, write, and understand English
• Interpersonal skills dealing with other departments/individuals in a team atmosphere
• Ability to read and interpret engineering drawings, product specifications, and procedures
• Ability to use metrology and other testing equipment
• Medical device experience desired

Skills

• Quality control
• Troubleshooting
• Caliper
• Micrometer
• Inspection
• QC
• Pneumatics
• Mechanical testing
• Electrical testing

Pay

$22.00 - $23.00/hr

Schedule

Contract to Hire, fully onsite in Allen, TX