Validation Engineer I supporting the AMI Validation Manager in process validation for medical devices. Focused on writing protocols and conducting validations for manufacturing processes.
Responsibilities
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
Responsible for writing of protocols and conducting validations of special processes, including laser marking, passivation, laser welding, molding, etc.
Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
Facilitate the execution of protocols by working closely with Engineering, Operations, Quality Control, and other manufacturing functions
Responsible for measuring validation parts and perform analysis of data generated from validations to evaluate process capability
Requirements
Bachelor’s degree in Engineering or Engineering related technology required
Experience in a Quality Control, Quality Assurance or Validation position in a Medical Device Company preferred
Knowledge of testing equipment, statistical methods, control plans
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software
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