Job Description
| QUALITY ENGINEER Position Specific Requirements Support Atrium product development teams throughout the development process Provide complete accurate quality plans for each assigned project This includes planning for product development design and process changes and additions to existing product lines Maintain quality plans at all stages throughout product life Maintain risk management files for all assigned product lines updating risk plans FMEAs and risk evaluations for returned product Implement validation activities using sound statistical principles and fully document them in compliance with the Quality Management System and applicable standards Support manufacturing changes to products and procedures insuring they are evaluated for risk and validation requirements Perform and analyze process capability studies designed experiments and special studies necessary to support departmental efforts Participate in cross functional design and development teams Assist in meeting departmental goals and in special projects as needed Qualifications Bachelorrsquos Degree in Engineering or Science A minimum of two years related manufacturing experience in a QMS environment Knowledge of Quality Assurance methods such as process validation design of experiments statistical process control (SPC) and protocolreport preparation Knowledge of ISO 13485 and FDA requirements Good analytical and problem solving skills High level of attention to detail and accuracy Strong computer skills including MS Office applications and statistical software are required Atrium Medical Corporation offers competitive salaries exceptional benefits and a business casual dress code We do not accept unsolicited Agency Resumes Atrium Medical Corporation is an equal opportunity employer dedicated to workforce diversity and a drug and smokefree environment Drug screening is required |
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