General Description

Assures the quality of Injection Works’ products and processes meet customer expectations through provision of Quality team support and application of advanced Quality tools, methods and analysis. Prior experience with injection molded parts is preferred. Inspects molded and assembled product or components for work quality, dimensional accuracy, conformance to drawings, internal specifications, and customer-supplied standards using precision measuring and testing instruments and equipment. Reports to the Quality Manager.

Duties and Responsibilities

Periodically verifies acceptance of shift production through visual and dimensional inspection to established standards and procedures.

Performs incoming inspection of purchased parts, assemblies, accessories, and materials for conformance to specifications as needed.

Aids with performance of First Article Inspections using a variety of inspection tools and techniques, compiling necessary data and completing reports per customer defined requirements.

Aids with major project data collection and reporting

Assists with process validations and process documentation

Acts as an assistant internal trainer of production staff on internal protocols, customer standards and other topics as necessary

Creates, updates, and modifies work instructions, inspection criteria, and other documentation as directed by Quality Manager

Demonstrates proficiency in blueprint reading, IQMS Quality module, and all applicable inspection equipment, gages, fixtures etc.

Ability to write vision system programs to assure consistent production inspection is performed across multiple shifts

Ensures proper inventory control and traceability by performing real-time inventory transactions related to nonconformances/rework/final release

Assists with preparation of Quality gages for external or external-on-site equipment calibration

In-depth understanding of ISO 9001/AS9100 and ISO 13485

Serves as internal ISO auditor

Provides input to Corrective Action teams with regards to non-conformances and continuous improvement initiatives.

Consults with Quality Manager regularly related to RC/CA documentation and investigation

Maintains a clean and orderly work area.

Provides information and suggestions for improvement of product, processes, and the quality management system.

Aids with updates to documentation and Quality system processes continually improve and

Performs additional tasks as delegated by the Quality Manager

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Qualification Requirements

General: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. A strong background in Word and Excel is essential.

Education: High school diploma or general education degree (GED); and a minimum of 5 years manufacturing experience and or training; or equivalent combination of education and experience. Knowledge of injection molding or ASQ certification is a plus.

Language Skills: Ability to write routine reports and correspondence. Ability to speak effectively to all employees with the organization, and occasionally interface with customers. Ability to comprehend and comply with written and verbal procedures, instructions, and assignments. Ability to deal with situations involving several variables in standard manufacturing conditions. Ability to actively participate in group problem solving activities.

Mathematical Skills: Ability to use ratios and percents and perform multi-step calculations. Experience with basic and advanced statistical analysis is required.

Reasoning Ability: Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to prioritize and balance multiple tasks simultaneously.

Other Skills and Abilities: Strong time management skills, experience working within a Medical Device and/or Cleanroom manufacturing environment is a plus

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand, walk, and use hands to finger, handle, or feel objects, tools, or controls. The employee must frequently lift and or move up to 10 lbs. and occasionally lift and or move up to 25lbs. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee occasionally works near moving mechanical parts and is exposed to humid conditions. The noise level in the work environment is usually moderate.