DHR Reviewer, 2nd Shift Position Available In Middlesex, Massachusetts

DHR Reviewer, 2nd Shift 3.0 3.0 out of 5 stars Wilmington, MA 01887 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.