Quality Engineer - Medical (Intern Hrly)

Position Summary

Apply quality engineering sciences and principles to all phases of product lifecycle: planning, development, qualification, manufacturing and continuous improvement.

Essential Duties and Responsibilities

• Supports product development, utilizing APQP (Advance Product Quality Planning) principles, including IQ/OQ/PQ validation process.
• Works from drawings, specifications, and inspection quality control instructions using an assortment measuring tools, fixtures and equipment such as micrometers, Verniers, gauge pins, height gauges, comparators, gear checkers, etc.
• Develops/implements programs to evaluate analytical testing, equipment, facilities, manufacturing processes, measurement systems and performance testing
• May develop and implement risk management tools (e.g., pFMEA, etc.) to incorporate into control planning strategies.
• Develops and implements standards and methods for inspection, testing and evaluation of materials, products and processes.
• Compiles and writes manufacturing and inspection instructions/protocols.
• Develops sampling procedures, designs and develops forms and instructions for recording, evaluating and reporting quality data.
• May direct quality department employees on processes for measuring, testing and tabulating data
• Will work independently and in a team environment to support the daily function of the manufacturing operation
• Will work with cross functional teams on continuous improvement projects
• Problem solving using formal CAPA tools.
• Investigate customer complaints and develop corrective action that mitigate the existing risk

This job description indicates the general nature and level of work, duties and responsibilities expected of the incumbent. The incumbent may be asked to perform other duties as required. The job description may be changed if needed as determined by the Company.

Qualifications

Required Competencies, Skills and Experience

• Strong analytical skills
• Desire for achieving excellence in customer satisfaction, process and product quality
• Strong detail-oriented written and verbal communication skills
• Knowledge of problem solving & root cause analysis tools (e.g., 8D, 5-Why, fishbone, cause and effect, etc.)
• Application of time management tools
• Knowledge of statistics including use of Minitab or similar statistics analysis software.

Education and Job Experience Requirements

• Working towards a four-year Engineering / Technical Degree.

Work Environment and Physical Demands

• Regularly required to sit and use hands
• Occasionally need to lift and/or move up to 10 pounds, with a potential of up to 25 pounds.
• Physical hazards from moving equipment and machine parts
• Sedentary, office environment; frequent exposure to manufacturing plant floor requiring the use of personal protective equipment (e.g., ear plugs, safety glasses, etc.) and following good manufacturing practices

The work environment and physical demands detailed above are representative of those encountered while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.