Mfg Lead Operator

Erbe USAorporated•Tempe, AZ

2d•Hybrid

About The Position

This position will be responsible for ensuring that manufacturing of items by team members are carried out efficiently and with strict adherence to quality standards. To operate manually and/or automated machinery to produce and assemble quality products. Safely performs the manufacturing, packaging, and labeling processes used in the Clean Room environment to ensure quality products are shipped on time to our customers. Operate, inspect, and troubleshoot production line machinery and/or assemblies. Follow documented work instructions, monitor materials, assemble products, and visually inspect parts to quality specifications. Assure accuracy of product packaging and tractability. Load/unload items from machines, carts, and dollies. Read and maintain accurate records. Maintain a clean and organized work area. Uphold safety and quality assurance standards. Detect quality defects in parts. Continuously provide supervisor with suggestions to improve equipment, tools, and processes. Pack and label acceptable product to specifications. Accurately complete Device History Records, Work Orders, and associated paperwork. Communicate effectively and positively with coworkers and staff. Utilize small hand tools and/or precision devices to aid in the manufacturing process. Follow and enforce all established safety, health, quality GMPs and all applicable SOPs. Performs other duties as assigned based on business needs.

Requirements

High School Diploma or equivalency
1+ year’s Lead Operator experience in manufacturing or equivalent experience preferred
Working knowledge of Microsoft Office applications
MRP/ERP experience preferred
3+ years of clean room experience
Experience following work instructions, process documentation, and procedures to ensure safe working conditions
A team-driven attitude to work together and support department initiatives such as 5S and Total Productive Maintenance Systems (TPM)
The ability to complete production paperwork, which includes inventory accuracy
Demonstrated communication and interpersonal skills
Excellent decision-making and problem-solving skills
Strong organizational skills
Medical device industry or regulated industry experience preferred
Excellent verbal and written communication skills
Must be dependable, reliable and have a good work ethic
Detail oriented – quality and precision focused
Team collaboration and development skills
Ability to produce high quality work in a high-volume environment
Ability to remain flexible and open to change within a fluid global industry
Employees must be legally authorized to work in the United States.
Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government.

Nice To Haves

1+ year’s Lead Operator experience in manufacturing or equivalent experience
MRP/ERP experience
Medical device industry or regulated industry experience

Responsibilities

Operate manually and/or automated machinery to produce and assemble quality products.
Safely perform manufacturing, packaging, and labeling processes in a Clean Room environment.
Operate, inspect, and troubleshoot production line machinery and/or assemblies.
Follow documented work instructions, monitor materials, assemble products, and visually inspect parts to quality specifications.
Assure accuracy of product packaging and traceability.
Load/unload items from machines, carts, and dollies.
Read and maintain accurate records.
Maintain a clean and organized work area.
Uphold safety and quality assurance standards.
Detect quality defects in parts.
Provide supervisor with suggestions to improve equipment, tools, and processes.
Pack and label acceptable product to specifications.
Accurately complete Device History Records, Work Orders, and associated paperwork.
Communicate effectively and positively with coworkers and staff.
Utilize small hand tools and/or precision devices to aid in the manufacturing process.
Follow and enforce all established safety, health, quality GMPs and all applicable SOPs.
Perform other duties as assigned based on business needs.