Assembler I

Job Title

Pay Range: $15hr - $20hr

Requirement/Must Have:

• High school diploma or GED.
• 2-5 years related experience.
• Basic communication and written skills.
• Assignments require limited judgment in troubleshooting proven processes.
• Will perform job in a quality system environment.

Responsibilities:

• Completing set-up operations for assembly, packaging, and prep operations in compliance with approved documentation and QSR.
• Performing routine tasks working from detailed written or verbal instructions.
• Assembling, repairing, inspecting, and/or testing products following written instructions.
• Assisting the Engineering and Maintenance teams with troubleshooting, maintenance, and repair of equipment.
• Completing and ensuring the accuracy of documentation associated with the manufactured product and equipment maintenance.
• Cleaning, performing, and documenting routine equipment maintenance and minor repair.
• Disposing of hazardous waste material in corresponding hazardous waste areas.
• Supporting continuous improvement activities, such as 5S and OEE.
• Supporting new equipment installation and validation.
• Assisting with problem-solving related to product quality.
• Reading and comprehending basic instructions and other work-related documents.
• Demonstrating strong customer service skills while maintaining product quality.
• Participating in root cause analysis and implementing corrective actions under the guidance of Supervisor or Manager.
• Collaborating with Engineers, Maintenance Technicians, QC Technicians, and Management to identify and help implement process improvements.
• Working on assignments that are semi-routine in nature where judgment is required in resolving problems and making routine recommendations.
• Understanding and being aware of the quality consequences which may occur from the improper performance of their specific job.
• Being aware of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities.
• Exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Carrying out duties in compliance with established business policies.
• Performing other duties as assigned, according to the changing needs of the business.

Nice to Have:

• 3 years’ experience preferable in medical device manufacturing.
• MS Office Suite experience.
• Knowledge of regulations (FDA, ISO, OSHA, etc.).
• Basic understanding of manufacturing systems (documentation, compliance, inventory control, production scheduling/controls, etc.).

Skills:

• 2-5 years assembling, filling, and packaging reagents experience.
• No blueprints experience needed.
• Packaging experience and ability to read work orders.
• Food environment experience also acceptable.
• Minimal Excel and basic computer skills.
• Most documentation is printed out and written (not digital).
• Ability to diagnose and perform routine technical troubleshooting.