Quality Specialist

Cogmedix•West Boylston, MA

21d•$21 - $28

About The Position

The Quality Specialist is a member of the quality organization with a high level of proficiency in a number of administrative functions. These functions include Material Review Board processing, incoming inspection, training, as well as support activities related to the documentation control group. The quality specialist must possess the appropriate skill set to support each of these functions with equal proficiency. Responsibilities: A Quality Specialist will maintain a specialty that will focus on primary responsibilities such as system administration, inspection processing and document control. Each Quality Specialist will also cross train in other areas of the quality organization to strengthen the department and company. Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO13485 requirements.

Responsibilities

Understands and follows good documentation practices in a cGMP and ISO 13485 environment.
Organize and review Device History Records (DHR’s) at the completion of the manufacturing cycle and ensure all signatures and data are present.
Scan Device History Records (DHR’s) to save electronically and upload to customer FTP sites.
Assists with maintaining the Quality System Documentation Control System including the Master list.
Assist the Quality management with the creation, updating, and processing of new and existing procedures, work instructions, and all other Quality department documentation.
Assists in the development and maintains associate training curriculum, which consists of documentation, training records, training matrix and materials.
Assists with maintaining project specific work instruction control forms.
Assists with preparing and delivering curriculum as necessary to support Cogmedix training needs.
Assists in providing Training Plan / Job Description for employees.
Files training logs within PLM System upon completion of training.
Creates training within PLM System as required.
Coordinates training classes when appropriate.
Must be proficient in the use of the PLM System Training module.
Assist the Material Review Board manager in the initial processing of non-conforming material into the electronic systems.
Organize materials to ensure the preservation of the materials
Able to effectively communicate issues to suppliers, both verbally and through email.
Prepare materials to be returned to suppliers.
Assists with gathering quality data for metrics and distribution of production metrics.
Able to assist Receiving Incoming Inspection by processing incoming material, that require incoming inspection, in the Cogmedix electronic systems.
Identifies and reports any product or documentation quality problems or discrepancies.
Ensures products are moved to proper locations as appropriate.
Documents any non-conformances and ensures all product non-conformance paperwork is complete and is included in the work order package.
Maintains proper control of device traceability materials and non-conforming material.
Maintains work area and equipment in a clean and orderly condition and follows prescribed safety regulations.
Perform all Quality Department administrative functions as required.
Assist with all FDA, Notified body, Internal and/or customer audit related activities; as needed.
Coordinate with Quality management on quality problems relating to the product, process and Quality System.
Performs other activities as directed.