Quality Engineer - Manufacturing

Job Description
Requisition ID:
Quality Engineer - Manufacturing
Arthrex Manufacturing Inc
Ave Maria, FL
These positions will support CNC machining operations at the Arthrex manufacturing facility in Ave Maria, FL.
Main Objective:
Responsible for supporting the Quality Manager with all quality related support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products.
Essential Duties and Responsibilities:
Responsible for participating in design and development projects and assuring the design process meets all requirements
Responsible for reviewing design drawings for tolerance, inspect-ability and quality of design issues
Work with suppliers to improve quality and assist, where necessary, in supplier process validations
Train and/or assist QC Manager in the training of QC Inspectors on inspection techniques and the use of new equipment
Participate in Internal and External quality audits as directed by the Quality Assurance Manager
Responsible for assisting in the design and development of methods and tooling for the test and inspection of articles
Responsible for assisting in maintaining vendor files in accordance with established procedures and SOPs
Responsible for writing and/or assisting in the writing of test and inspection SOPs
Responsible for assisting in complaint investigations as related to product quality
Responsible for assisting in compiling and reporting on Vendor performance statistics
Responsible for filling in for absent QC technicians and the Document Control Specialist as directed by the QA Manager
Other duties as assigned
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor's Degree in an Engineering discipline required. At least three years' experience in a Quality Control or Quality Assurance position required, preferably in a Medical Device Company.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of testing equipment, statistical methods, control plans.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Mathematical Skills:
Ability to comprehend and

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