Manufacturing Operator II

Erbe Medical, LLC; Tempe (AZ); On-site; USD 38,000 - 60,000; Full time

Job summary

Erbe Medical, LLC in Tempe, AZ is seeking a Manufacturing Associate to operate and troubleshoot production line machinery in a regulated Clean Room environment. You will follow work instructions, assist in packaging, labeling, and maintaining records while upholding safety and quality standards.

Ideal candidates have a High School diploma, 0-3 years' clean room experience, and strong teamwork, communication, and problem-solving skills.

Qualifications

• High School Diploma or equivalency
• 0-3 years of clean room experience in a regulated Industry
• Ability to read and follow work instructions, process documentation, and procedures
• Team-driven attitude to work with TPM/5S initiatives
• Ability to complete production paperwork including inventory accuracy
• Excellent communication and interpersonal skills
• Experience in medical device or regulated industries preferred

Responsibilities

• Operate, inspect, and troubleshoot production line machinery and 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 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
• Complete Device History Records and associated paperwork
• Communicate effectively with coworkers and staff
• Use small hand tools and precision devices to aid manufacturing
• Follow SOPs and GMPs
• Demonstrate mastery of product line stations with accuracy and efficiency
• Perform other duties as assigned

Skills

Teamwork

Communication

Problem Solving

Detail-Oriented

Organizational Skills

Quality Assurance

Safety Compliance

Education

High School Diploma or equivalent

Tools

Hand tools

Job description

This position will be responsible 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 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 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 all applicable SOPs and GMPs
• Demonstrate a mastery of product line stations at a high level of accuracy and efficiency
• Performs other duties as assigned based on business needs

Supervisory Responsibility

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.

Physical Demands

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.

Position Type and Expected Hours of Work

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 Friday and weekend work may be required as job duties demand.

Travel

This position requires no measurable travel.

Required Education and Experience

• High School Diploma or equivalency
• 0-3 years of clean room experience in a regulated Industry.
• 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.

Position Requirements

• Excellent verbal and written communications required
• 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

Additional Eligibility Qualifications

English and Spanish language proficiency candidates welcome.

Work Authorization/Security Clearance

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.

AAP/EEO Statement

Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non‑merit‑based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs.

Other Duties

Please note this position description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

At-Will Employment

This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employment-at-will rights at any time.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.