QA Engineer II - Validation

This position will be located at the Arthrex manufacturing facility in Sandy Springs, SC.  The successful candidate for this position must be able to attend initial training in the Naples, FL area if/as needed by Arthrex.

Main Objective:

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:

1. Responsible for writing of protocols and conducting validations of special processes, including cleaning and passivation, electropolishing, molding, etc.
2. Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
3. 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 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.