Experience Requirements
To be knowledgeable in researching, writing, and performing installation qualification (IQ) Operation Qualification(OQ) Process Qalification (PQ), QSR's and ISO Standards, writing and maintaining CAPA's and Non-conformances. To track internal quality issues and report on corrective action progress. This would also include performing failure investigation and make recommendations for corrective actions. Write document changes and modify procedures in accordance with document change procedures.
Qualification Requirements
Associates Degree or equivalent experience. 2-5 years min. in a similar Manufacturing environment.
Preferred Qualifications
Familiar with Medical Device industry.
Responsibilities
The Quality/Process Engineer shall support the facility and departments in the development, implementation, and maintenance of the quality system. This includes supporting the quality and manufacturing departments. To help in the support of current test and inspection methods. To help evaluate current test and inspection methods, to identify areas for improvement, efficiency and cost reductions. Work with engineering and manufacturing to establish consistent and effective quality evaluations for components and finished goods which would include FMEA's and Risk analysis. Act as Quality designee on Management Review Board. Perform internal audits. Perform other related duties as required.
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