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Quality Assurance Programming Technician II

4 months ago

Agoura Hills, United States Paragon Implant MFG LLC Full time
Job DescriptionJob DescriptionDescription:

Create programs to automate product inspection processes on computerized inspection equipment (Keyence LM & Vision System SeeBrez) to verify dimension, tolerance, functionality, configuration, aesthetics, surface finish, plating, and material per inspection methods outlined on First Article, On-line, and Final inspection guidelines. Coordinate with Tooling personnel on design and configuration of new gages and fixtures to expedite inspection processes. Evaluate current inspection methods and trends to identify process improvements. Responsibilities include inspection of, in process, outsourced, purchased, and modified products following cGMP compliance for Class II medical devices.


The position will be based out of Calabasas, California. Benefits
  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • 401(k)
  • PTO
  • Vacation
  • Sick
  • Holiday Pay


Responsibilities

  • Create simple to complex programs to automate mechanical / dimensional inspections for first article, in-process, and final inspections per blueprints and/or other written specifications on designated inspection equipment such as optical computerized numerically controlled measuring systems.
  • Calculate and set controls for inspection equipment to regulate proper and most efficient product inspection methods.
  • Start up and observe operation of measuring inspection equipment and programs to ensure proper operation and detect malfunctions or out-of-tolerance concerns. Adjust machine controls and program settings as required.
  • Train employees on all automated and mechanical inspection equipment.
  • Identify and provide direction on improving inspection methods, including gages and fixtures to expedite inspection processes.
  • Perform simple to complex mechanical / dimensional inspections for first article, in-process, and final inspections per blueprints and/or other written specifications using designated inspection equipment such as optical computerized numerically controlled measuring systems.
  • Inspect product within the estimated time requirements.
  • Document part numbers, lot numbers, quantities, inspection dates, results, in log entry format to ensure accurate product history records for each product inspection task performed.
  • Report all non-conforming product(s) to the Quality Manager.
  • Obtain appropriate inspection gages, fixtures, attachments, accessories, and materials necessary to perform inspections.
  • Inform machine operators of any out of tolerance conditions or acceptability of product based on specification.
Requirements:


  • A minimum of eight (8) years quality assurance mechanical inspection experience, or a combination of education and/or experience.
  • Experience with Keyence IM series or LM Series inspection system programming.
  • Able to perform product traceability tasks by reviewing the product history, researching, and investigating all steps and processes pertaining to the specific product to ensure the effectiveness of the Quality System.
  • Ability to write reports and business correspondence.
  • Experience with ANSI Y14.5 Geometric Tolerance and ANSI Z 1.4 Sampling Plan.
  • Ability to effectively present information and respond to questions and communicate clearly with others while maintaining a high level of professionalism.
  • Ability to apply common sense understanding to carry out detailed written and/or oral instructions. Being able to quickly assess large amounts of information and data is very important. The ability to consider and evaluate the interrelationships of numerous factors and to select the best course of action is imperative. In the absence of sufficient information, sound intuitive judgment is crucial to reaching favorable decisions. Certain qualities, including self-confidence, motivation, decisiveness, and flexibility, as well as the ability to apply sound business judgment are important.
  • Strong Microsoft Office: Outlook, Excel, and Word.
  • Understanding of thread specifications and classifications.
  • Advanced understanding of calibration programs.
  • Basic experience working with a statistical process control program.
  • Interpret and comprehend Engineering blueprints / drawings.

Preferred:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel objects. The employee frequently is required to sit, stand, walk, reach with hands and arms, and talk or hear and will occasionally be required to bend, stoop, kneel and climb stairs.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Other:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee occasionally works near moving mechanical parts. The noise level in the work environment is usually moderate to loud.