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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