Production Operator - 8-Hour Shifts

Job Summary

In this role, you will be responsible for the production of components that meet or exceed pre-determined specifications. Responsible for inspection, packaging, labeling, and completion of documentation necessary to provide quality, production, and traceability records in accordance with Quality Systems ISO 9001/ ISO 13485.

Essential Duties and Responsibilities

• Ensures the quality of the parts produced by inspecting parts visually.
• Ensures all relevant documentation is recorded and signed off in real time.
• Always maintains accuracy of batch documentation and ensures that it is filled in and is right the first time.
• Completes measurements, as required by the work instructions, reviews measurement results, and alerts appropriate personnel of any deviations from the customer specifications or part print.
• Packages the parts according to customer specifications and indicates the status of the part (accept/reject) according to proper procedures and specifications.
• Places the finished product in the correct location.
• Understands and safely operates all equipment.
• Reports and/or corrects unsafe working conditions.
• Performs secondary operations as necessary to meet customer specifications.
• Performs general cleaning of machines and ancillary equipment.
• Verifies the labels for correct part and lot numbers.
• Maintains proper levels of packaging supplies at each machine.
• Maintains work areas in a clean and orderly manner by practicing good housekeeping.
• Defines machine status on OEE System to determine machine downtime and run time.
• Compliance with all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance with all local site company polices, procedures, and corporate policies.
• Supports and contributes to Lean Sigma programs and activities towards the delivery of the set target.
• Acts in accordance with the company's guiding principles and adherence to the corporate Code of Conduct.
• Performs additional duties at the request of the direct supervisor.
• Maintains methods/procedures and all supporting documentation to meet the requirements of Quality Systems ISO 13485:2016.

Requirements

• High School Diploma or GED required.
• Previous production work experience would be an advantage.
• Knowledge of Good Manufacturing Practices (GMP) requirements would be an advantage.

Preferred Knowledge, Skills, and Abilities

• Must have good verbal reasoning, numerate ability, and mechanical aptitude skills.
• Must have good communication skills, both written and oral.
• Must have good organizational skills.
• Must be able to work in a team environment.
• Basic knowledge and understanding of a computer.
• Must be willing to work in a controlled environment, which involves the wearing of a gown, cap, and relevant personal protective equipment.

Schedule

• 3rd Shift: Sunday - Thursday: 11:30PM - 8AM

Travel Requirements

• 5%: Up to 13 business days per year

Physical Requirements

• Medium - Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.