Job Details

Job Title

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

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