DHR Reviewer

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.

• 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.

• 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.