Job title: DHR Reviewer/Inspector 

Status: Non-exempt  

Job Summary:

The DHR Reviewer/ Inspector will be responsible for product quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing and product release activities. 

Duties and responsibilities:

·       Develop and maintain strong internal working relationships across restor3d. 

·       Understand the objectives, responsibilities, and mission of the Sterility & Lot Release department and work towards those goals. 

·       Prioritize and plan work activities; adapt for changing conditions. 

·       Review labels for accuracy and precision. 

·       Review of Device History Records to perform release of sub-assemblies and finished goods. 

·       Inspect finished parts, and materials for conformance to quality control standards. 

·       Initiate and participate in resolution of non-conforming materials. 

·       Responsible for final product release sign-off. 

·       Other responsibilities as assigned. 

·       Qualifications and experience 

Qualifications and Experience:

·       Excellent written and verbal communication skills. 

·       Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. 

·       Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. 

·       Strong organizational, analytical, and time-management skills. 

·       Able to be self-motivated and work both independently and as part of a team. 

·       Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have high attention to detail. 

·       Knowledge of FDA and ISO standards for Medical Devices is a plus. 

·       Ability to multi-task, perform efficiently, and independently.