Title:  Production Operator/Backup Lead

Job Summary

Schedule- 8 hour- 3rd shift

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.  This role will also assists the Production Supervisor and Production Lead in the daily operations of the Direct Labor Department.  Assist with coordinating all activities of the weekend workforce.  .

Essential Duties and Responsibilities

.Production Operator:

• Ensures the quality of the parts produced by inspecting parts visually, ensures relevant documentation is recorded and signed off in real time.
• Maintaining accuracy of batch documentation at all times and ensuring that it is filled in and right first time.
• Completing measurements as required by the work instructions, reviewing measurement results and alerting appropriate personnel of any deviations from the customer specification or part print.
• Packages the parts according to customer specification and indicates the status of the part (accept/reject) according to proper procedure and specifications.
• Places finished product in 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 level 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 in order to determine machine downtime and run time.
• Compliance to all site Environmental, Health and Safety requirements, training and regulations.
• Support and contribute 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.
• Maintains methods/procedures and all supporting documentation to meet the requirements of Quality Systems ISO 13485:2016.

Additional Responsibilities

Team Leader

• Partners with the Full Time Team Leader to coordinates and supervisor all activities of the weekend workforces; works every other weekend.
• Take over information at shift change, using Excel to prepare shift change papers.
• Perform basic troubleshooting, cleaning, and maintenance tasks on molding and finishing equipment as directed.
• Utilize Intouch for production scheduling, tracking, and capturing data.
• Prepare production shop packets and labels. Review completed shop packets for accuracy.
• Issue non-conforming material reports when defective lining material, bags, etc. are found.
• Basic use of SAP: checking inventory balances, locating products and materials.
• Responsible for Central Stores activities as needed.
• Maintain a routine presence on the production floor to monitor and support all activities.
• Give break(s) as required.
• Work on special projects as directed by the Production Supervisor.
• Monitor alarm systems for the facility and facilitate emergency response activities as designated.
• Accident response, reporting, and investigation.
• Ensure policies, rules, regulations, and procedures are followed.  Report and document incidents.
• Edit Kronos.
• Follow call-in instructions on off-shifts and weekends to obtain coverage for all essential production activities.
• Contact department managers if circumstances arise that require their input.
• Train new hires on job functions in addition to certifying on procedures.

Education

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

Work Experience

• No min required

Preferred Knowledge, Skills and Abilities

• Must possess an acute attention to detail
• Basic computer skills, i.e. use a mouse/keyboard.
• Ability to apply Good Manufacturing Practices (GMP)
• General use of computer work station and ability to use SAP commands is preferred
• Must be willing and able to work as a team member and make general decisions within authorized job responsibilities
• Must be able to train and guide others as required.
• Must be able to read and write in English

License and Certifications

Travel Requirements

Physical Requirements

Additional Requirements