Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.
Quality Control Technician – direct hire / full-time
Quality Operations Assistant Manager
1st Shift Monday to Friday, 7 AM – 5:30 PM (10 hour shift)
Allen, TX 75002
Inspect incoming raw materials pertaining to Disposables, Electronics and Finished products. 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.
High school graduate or equivalent work-related experiences with some previous Quality Control experience desired (prefer 2-5 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 Excel and MS Access (basic knowledge of each).
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.
Ability to test components, in-process subassemblies and finished products and review documentation
Ability to use pallet jack to move materials
Ability to lift materials weighing up to 50 lbs.
Medical device experience desired.
Experience working within an ISO 13485 / FDA regulated environment
Ability to use a forklift a plus
Review processes to assure procedural compliance and recommended improvements
Perform and review visual, dimensional and functional inspection of incoming raw materials pertaining to Disposables and Electronics. Ability to identify key inspection points and the proper tools / equipment to ascertain these points.
Perform inspections on components, in-process subassemblies and finished products
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).
Use recognized sampling plans to determine statistical size of samples.
Perform and review tests according to various protocol requirements.
Use functional test fixtures for components, subassemblies, and finished devices.
Document inspection results per GMP / GDP and verify final counts.
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
Ability to work in all QA areas (IQC, in-process, and finals) if needed.
Provide/coordinate training for new QC Technicians.
Notables / Benefits:
Mid-size company with great company culture that is well diverse
Have a voice in the company
Average tenure for employee population is 7+ years