Lead Manufacturing Operator - Irvine, United States - Axonics Modulation Technologies
Description
FLSA
- Hourly, Non-Exempt
Department - Operations
Reports To - Production SupervisorGeneral Description:
This involves working in a variety of work-cells, utilizing an assortment of handheld and electronic tools to assemble components, and up to final packaging.
The Lead Manufacturing Operator will work with the Development, Operations and Quality depts to achieve an in-depth knowledge of the production tools, methods and documents needed to comply with stated requirements in the build process.
Duties/Responsibilities:
Under the direction of the Production Supervisor, participate in and train operators in all aspects of Manufacturing of Axonics' products, including quality inspection and record keeping in accordance with established company procedures and GMP/GDP.
- Verify that correct components are used.
- Follow all established procedures and policies.
- Perform necessary quality checks relative to the operation.
- Perform viable inspections during process operation per procedure.
- Inspect components, materials and product for proper identification, acceptable quality and correct quantity.
- Ensure manufacturing equipment has necessary supplies and materials for the operation.
- Report quality deviations to the production supervisor.
- Perform line clearances.
- Complete appropriate documentation.
- Perform cleaning, sanitizing, and disinfecting of designated manufacturing areas.
- Maintain work area in neat and orderly condition.
- Adhere to all safety and good housekeeping regulations.
- Perform minor troubleshooting to resolve machine stoppages.
- Good communication skills with ability to read, write and understand job language in English.
Position Requirements:
- Possess a High School Diploma/GED or higher.
- Minimum of 2 years manufacturing experience (Medical Device Manufacturing preferred).
- Ability to work quickly and independently.
- Ability to work with numbers and perform calculations or conversion.
- Computer skills in Microsoft Word/Excel.
- Excellent communication skills.
- Attention to detail and accuracy.
- Ability to lift up to 50lbs.
- Have a great attitude and be a team player.
This Position May Require:
- Working overtime.
- Weekend work.
- Working holidays as needed.
This is a 2nd shift Lead role.
This is an hourly, non-exempt role.
Experience Requirements:
- Med device background
- Minimum 2 years manufacturing experience
- 35 years Lead experience
- Experience leading a team on 2nd> shift
- Requesting to train on swing shift hours 9:00am5:30pm for first month
- Half hour overtime required every Tuesday, arriving at 2:30pm to participate in Lead meeting
- Potential overtime with notice
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