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Manufacturing Line Operator
2 months ago
Quality Management System Requirements
Functional Area
Requirements
Training and personal development
· Ensure efficient and effective training on internal and external customer requirements
· Learn products and processes to appropriately support the customers and business
· Utilize IT tools for efficient execution of duties
Specific areas of responsibility – including regulatory and overall compliance
· Knowledge of Quality Management System
· Working knowledge of standards and regulations as outlined in the QMS documentation and structure
· Understanding that device defects may occur from improper performance of specific job function, including when performing validations.
· Understanding of individual role in achieving company quality objectives and QMS compliance.
· Performs all assigned tasks and duties in a safe and efficient manner
· Maintains clean work areas and equipment, performing housekeeping activities as required
Improvement
· Receive feedback from customers for individual and company improvement
· Identify opportunities for improvement, prevent nonconformances
Communication, trust, and accountability
· Professional written and oral communications
· Ethics aligned with the company’s mission
· Personal accountability
Time management and organization
· Utilization of IT tools provided to ensure work is organized to prevent errors and omissions
· Work product for clients is organized, reviewed and complete
Policy adherence to company policies
· Adherence to company policies and employee handbook
Customer Focus
· Adaptability to communicate with various clients with diverse cultures and personalities
· Ability to communicate with all levels within the organization and with customers, as needed
Additional Responsibilities – Job Specific
Functional Area
Requirements
Quality and Regulatory
· Follows procedures as assigned.
Preproduction
· Drain unused material from finished runs
· Fill out material return forms
· Bring labeled unused material back to designated area
· Clean hopper/mixer and material cone
· Remove runner or parts to be reground (or thrown away) from around the machine
Production Set Up
· Load up material for the current run
· Read and sign that you understand work instructions
· Scan the machine in at the beginning of production
Production Run
· Ensure hopper/mixer stays full
· Properly fill out box labels
· Review parts for known quality issues
· Properly package and box all parts
· Scan In all jobs when starting in Production
· Remove completed boxes from the machine before the end of shift
· Complete any necessary regrinding before end of shift
· Keep machine and work area clean at all times
· Communicate necessary training, quality concerns, and finding to
next operator at shift change
Post Production
· Scan at the end of the production run with final part count
· Record number of total scrap at the end of the shift or run
· Remove all labeled boxes from the machine at the end of the shift or run
· Turn work order in completed with all blanks filled in
Education and Experience
Read and understand job specific instructions
Comfortable in operating a calculator
Can operate a scale to weigh products
Knowledge of inspection equipment (gages) and proper usage
Capable of lifting boxes up to 70lbs
Able to operate handheld scanner to input job information
Can be trained to uphold quality standards
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