Mfg Lead Operator at Erbe Medical, LLC in Tempe, Arizona

Job Description:

Essential Responsibilities

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

Supervisory Responsibility

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

Work Environment

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 evening 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

Preferred previous Lead Operator experience in manufacturing or equivalent experience

Working knowledge of Microsoft Office applications

Preferred MRP/ERP experience

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.

Position Requirements

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.

Competencies

Problem Solving/Analysis

Results Driven

Detail Orientation

Customer Focus

Technical Capacity

Communication Proficiency 

Additional Eligibility Qualifications

None required for this position. 

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

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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