Job Description

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.  

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