Responsible for supporting the AMI Validation Manager with all process validation related support for the life cycle development and manufacturing of Class I, II and III medical devices.
Essential Duties and Responsibilities:
Responsible for writing of protocols and conducting validations of special processes, including cleaning and passivation, electropolishing, molding, etc.
Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
Other duties as assigned
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 preferably in an Engineering or Science discipline. At least three 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.
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Arthrex is a global medical device company and leader in new product development and medical education in orthopedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 11,000 innovative products and surgical procedures to advance minimally invasive orthopedics worldwide.
Arthrex continues to experien...ce unprecedented growth and demand for our products throughout the world; however, we remain a privately held company with a family business culture committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.
We invite you to learn more about Arthrex and the positive contributions we are making to medicine and the communities we serve.