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Manufacturing Line Operator
1 month 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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