Mfg Lead Operator

Join to apply for the Mfg Lead Operator role at Erbe USA Incorporated

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.

• Operates, inspects, and troubleshoots production line machinery and/or assemblies
• Follow documented work instructions, monitor materials, assemble products, and visually inspect parts to quality specifications
• Assures accuracy of product packaging and tractability
• Load/unload items from machines, carts, and dollies
• Reading and maintaining accurate records
• Maintaining clean and organized work area
• Upholding 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 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
• Follows and enforces all established safety, health, quality GMPs and all applicable SOPs
• Performs other duties as assigned based on business needs

This position is an individual contributor and has no direct supervisory responsibility.

This position operates in an office and manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The position also interacts with machinery on the manufacturing floor and numerous devices that are sold by the company.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and stoop; use hands to finger, handle or feel; and reach with hands and arms.

The employee frequently is required to lift and/or carry up to 20 pounds. For more information, please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.

This is a full-time position. Days and hours of work are Monday through Thursday, 5:30 a.m. to 4:00 p.m. Occasional evening and weekend work may be required as job duties demand.

This position requires no measurable travel.

• High School Diploma or equivalency
• Preferred previous Lead Operator experience in manufacturing or equivalent experience
• Working knowledge of Microsoft Office applications

• 0-3 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 communications required
• Must be dependable, reliable and have a good work ethic
• Detail oriented – quality and precision focused
• Team oriented
• Must be detail-oriented and produce high quality work in a high-volume environment
• Ability to remain flexible and open to change within a fluid global industry

• Problem Solving/Analysis
• Results Driven
• Detail Orientation
• Customer Focus
• Technical Capacity
• Communication Proficiency

• English and Spanish language proficiency candidates welcome