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QC Technician

2 months ago

Allen, United States Quest Medical, Inc. Full time

Summary:

Ability to inspect in-process and finished products in the cleanroom environment. Act as coordinator within Quality Operations and ensure needs of internal customers are met. Document all non-conformances when necessary. Assist with investigations pertaining to, both, customer complaints and internal non-conformances. Understand, follow, and practice the rules/regulations set forth by the QSR, ISO 13485, and Quest Medical management.


General Duties and Responsibilities:

  • Review processes to assure procedural compliance and recommend improvements
  • Provide support during internal, customer and regulatory audits
  • Ability to identify key inspection points and the proper tools/equipment to ascertain these points.
  • Perform inspections and verification of finished products.
  • Perform Line clearance and in-process inspections.
  • Review inspection data and DHRs (including sterilization records) for accuracy and compliance to the applicable standard(s).
  • Perform inspections and process Returned goods/ materials (RGAs/RMAs).
  • Evaluate materials for extending Expiration dates.
  • Use recognized sampling plans to determine statistical size of samples
  • Perform and review tests according to various protocol requirements
  • Document and review inspection results per GMP/GDP.
  • Provide/coordinate training for new Technicians.
  • Generate non-conforming material reports (NCMR) for products that do not conform to test specifications and contact the appropriate personnel.
  • Communicates needs of department/company to management.
  • Coordinate needs of internal customers and communicate to technicians in his/her area of responsibility.
  • Assist engineering staff with process improvement projects regarding improved quality inspection of product and components (such as First Article Inspections and qualification testing)
  • Evaluate certification status of raw materials under the Supplier Certification program.
  • Ability to work in Quality Operation areas Cleanroom In-Process QC, Finals QC.
  • Ability to work on projects related to new instrumentation.
  • Ability to redline documents for improvements or compliance.
  • Ability to use pallet jack to move materials.
  • Ability to lift materials weighing up to 50lbs.


Qualifications:

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