Work schedule: M-TH 4:00am-3:00pm
Under little or no supervision, function as a line lead of the production team whose goal is to assemble required components, operate tools & equipment, inspect in-process components, complete documentation as required and maintain a high level of quality and integrity of products at all time. Lead as a role model for good manufacturing practices, adherence to processes and procedures, and report issues such as non-conforming events to Shift Supervisor.
Specific duties & responsibilities:
- In charge of on-the-job training on an as needed basis and responsible for leading a team
- Requesting material for team and material verification
- Assist team in manufacturing parts and/or troubleshooting when needed
- Responsible for returning all material when project completed
- Responsible for Quality – 100% adherence to the manufacturing process requirements, such as daily in-process inspection and documentation control
- Assist in root cause investigation of nonconforming products and supplier corrective action as assigned.
- Ensure proper cGMP, such as labeling and documentation
- Conducting daily in-process inspection
- Collect and report data to Shift Supervisor and expected to manufacture 75% of the time
- Take initiative to find work when necessary and identify continuous improvement initiative and working with Shift Supervisor
- Additional duties as assigned.
Experience & education requirements:
- High school diploma or GED or related work experience and/or training.
- Must be willing to work in team environments and promote teamwork among others.
- Demonstrate a clear understanding of safety and Shop Floor Paperwork.
- Understand basic blueprints/specifications
- General math skills with metric conversions
- 1 to 3 years of medical device experience in clean room
- Working knowledge of ISO 13485 and cGMP
- Basic computer skills: Excel, Word
- Physical Requirement: lifting and moving up to 50lbs, must be able to work with a microscope, and sit for an extended period of time.
Benefits: Medical, Dental, Disability, Life insurance, Paid time off, and 401K