Job Description
Job Description
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 :
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.