Duties and responsibilities
- Operate and monitor automated production lines used to manufacture medical devices.
- Set up automated equipment according to Standard Operating Procedures (SOPs).
- Perform basic equipment troubleshooting and use common hand tools.
- Perform in-process quality checks to ensure products meet quality requirements.
- Use calipers to perform measurements as required.
- Complete batch records and production documentation following Good Documentation Practices (GDP).
- Follow cGMP, safety, quality, and FDA-regulated manufacturing requirements.
- Maintain a clean and sanitary work area.
- Identify and suggest opportunities for process improvement.
- Work at different production workstations based on manufacturing needs.
- Work collaboratively in a fast-paced manufacturing environment.
- Assist less-experienced team members as knowledge and experience are gained.
- Maintain reliable and punctual attendance.
- Perform other duties as assigned.
Qualifications
- High school diploma or equivalent.
- 2+ year of manufacturing, production, machine operation, or related experience preferred.
- Automated equipment experience is a plus but not required.
- Ability and willingness to learn equipment setup and basic troubleshooting.
- Ability to use or learn to use calipers and common hand tools.
- Ability to understand work instructions and follow written procedures.
- Strong attention to detail when performing quality checks and completing production records.
- Ability to prioritize work and complete assigned tasks with limited supervision.
- Ability to work effectively as part of a team.
- Willingness to learn and participate in continuous-improvement practices, including Kaizen, 6S, KPI tracking, Gemba walks, and SQDC.
- Ability to lift up to 50 lbs. and work around moving mechanical equipment while wearing required personal protective equipment.
- Legally authorized to work in the United States.
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