SUMMARY The Quality Control (QC) Inspector II works in a timely manner to execute the required duties and responsibilities of this position. The Quality Control Inspector II position works with the Operations and the Quality Teams to promote quality management throughout the facility in order to ensure product quality levels are consistent with Company standards and customer expectations. The QC Inspector II is mindful of opportunities for continual improvement of manufacturing and inspection processes to increase quality, reduce waste, and improve efficiencies. The QC Inspector II is aware of regulatory requirements and reduces product liability by mitigating risk through quality management. ESSENTIAL DUTIES AND RESPONSIBILITIES
- Adhere to the Company's Quality Management System to ensure compliance with applicable regulatory requirements.
- Inspect device components and finished devices following inspection instructions and established procedures.
- Inspect device components using manual and advanced video inspection equipment in the facility.
- Maintain and create new inspection procedures as required.
- Communicate inspection results to Quality Supervision and other team members as required.
- File quality documents and records and maintain quality files.
- Assist with process validation work to support manufacturing needs, if required.
- Assist new employees with understanding inspection processes, methodologies, and quality procedures.
- Perform special assignments as directed by supervision commensurate with experience.
- Perform other duties as assigned.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
SUPERVISORY RESPONSIBILITIES Direct Reports: Yes N/A QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Two to five years' experience in an industrial manufacturing, quality manufacturing, or industrial medical device manufacturing environment required.
- Able to use manual inspection instruments including, but not limited to micrometer, calipers, optical comparators, toolmakers, etc. required.
- Able to read and understand blueprints.
- Able to locate and measure dimensions such as length, angle, arcs, radii, etc.
- Experience with computerized record-keeping (e.g., documents, drawings) preferred.
- Computer literacy with standard software applications.
- Excellent written and verbal communication skills.
EDUCATION AND/OR EXPERIENCE
- High School diploma or equivalent preferred.
- Two years' inspection experience required.
CERTIFICATES, LICENSES, REGISTRATIONS None 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. The manufacturing environment is an industrial setting dedicated to the production and assembly of medical devices that utilizes machinery, equipment, and specialized processes to transform raw materials into finished products. This position's time is split between office and manufacturing environments. Occasionally, the Team Member in this position may be asked to work a split-shift for training and meeting purposes. PHYSICAL DEMANDS
Analysis of Physical Demands N =Never, R = Rarely Less than 1 hour per week, O = Occasional 1% to 33% of time, F = Frequent 34% to 66% of time C = Constant over 66% of time |
Activity |
Frequency |
Activity |
Frequency |
Lifting/Carrying |
N |
R |
O |
F |
C |
Twisting/Turning |
N |
R |
O |
F |
C |
Under 10 lbs |
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Reach over shoulder |
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11-20 lbs |
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Reach over head |
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21-50 lb |
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Reach outward |
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51-100 lbs |
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Climb |
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Over 100 lbs |
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Crawl |
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Pushing/Pulling |
N |
R |
O |
F |
C |
Kneel |
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Under 10 lbs |
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Squat |
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11-20 lbs |
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Sit |
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21-50 lbs |
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Walk-Normal Surfaces |
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51-100 lbs |
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Walk-Uneven Surfaces |
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Over 100 lbs |
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Walk-Slippery Surfaces |
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Other |
N |
R |
O |
F |
C |
Stand |
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Keyboard/Ten Key |
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Bend |
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Fingering (fine dexterity) |
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Driving |
N |
R |
O |
F |
C |
Handling (grasping, holding) |
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Automatic Trans |
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Repetitive Motion - Hands |
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Standard Trans |
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Repetitive Motion - Feet |
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2nd shift: Monday - Thursday 3:45 pm - 1:45 am
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