Arthrex Manufacturing, Inc.
Sr QA Validation Engineer - Cleaning (Engineering)
This Sr QA Validation Engineer - Cleaning is responsible for supporting the Arthrex Manufacturing Validation Manager with all Cleaning process validation related support for the life cycle development and manufacturing of Class I, II and III medical devices & acts as the Cleaning validation SME to assist in NCR investigations related to contamination.
Essential Duties and Responsibilities:
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 required in an Engineering or Engineering Technology discipline. At least seven years of Process Validation work experience required, preferably within a Medical Device Company.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of testing equipment, statistical methods, control plans.
Knowledge of cGMP and GDP requirements.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP or similar inventory software and MiniTab.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.