Quality Assurance Inspection Technician

JOB SUMMARY: 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. Evaluate current inspection methods and trends to identify process improvements. Responsibilities includes inspection of, in process, outsourced, purchased, and modified products following cGMP compliance for Class II medical devices.

ESSENTIAL DUTIES:

INSPECTION

1. 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.
2. Inspect product within the estimated time requirements.
3. 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.
4. Report all non-conforming product(s) to the Quality Manager.
5. Obtain appropriate inspection gages, fixtures, attachments, accessories, and materials necessary to perform inspections.
6. Inform machine operators of any out of tolerance conditions or acceptability of product based on specification.

MINIMUM REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE: High School diploma required; some college or technical training preferred. A minimum of eight (8) years Quality Assurance mechanical inspection experience required, or a combination of education and/or experience.

LANGUAGE SKILLS: Ability to write reports and business correspondence. Ability to effectively present information and respond to questions and communicate clearly with while maintaining a high level of professionalism.

REASONING ABILITY: 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 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.

OTHER SKILLS and ABILITIES:

1. Strong Microsoft Office: Outlook, Excel and Word.
2. Experience with ANSI Y14.5 Geometric Tolerance and ANSI Z 1.4 Sampling Plan.
3. Experience with Keyence IM series or LM Series inspection system use.
4. Understanding of thread specifications and classifications.
5. Advanced understanding of a calibration program.
6. Basic experience working with a statistical process control program.
7. Interpret and comprehend Engineering blueprints / drawings.

PHYSICAL DEMANDS: 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.

WORK ENVIRONMENT: 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.