Production Operator - 12-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, labelling 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.
• Ensure relevant documentation is recorded and signed off in real time.
• Maintains the accuracy of batch documentation at all times and ensures that it is filled in and right the first time.
• Completes measurements as required by the work instructions, reviewing measurement results and alerting 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.
• Define 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 policies, procedures, and corporate policies.
• Supports and contributes to Lean Sigma programs and activities towards delivery of the set target.
• Act 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.

Education

High School Diploma or GED required

Work Experience

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.

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.

Shifts

2-2-3 schedule (2 week rotation/rolling roster) Nights: 5:30PM – 6AM Days: 5.30AM-6PM. Please note: Training takes place on days for the first week.