Quality Specialist
Full Time • Cogmedix - 127 Hartwell Street
Description:
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.
Documentation Control:
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.
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.
Training
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 deliver curriculum as necessary to support Cogmedix training needs.
Assists in providing Training Plan / Job Description for employees.
Files training logs within Omnify upon completion of training.
Creates training within Omnify as required.
Coordinates training classes when appropriate.
Must be proficient in the use of the Omnify Training module.
Material Review Board
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.
Production Quality
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.
Essential Requirements:
Positive attitude, self-motivator and tenacious follow up.
Attention to details and superior organizational skills.
Superior customer service attitude.
Demonstrated skills in administrative roles.
High School Diploma or equivalent. Further technical training or education preferred.
Working knowledge of cGMP, QSR, ISO, SOP’s, work rules and safety guidelines preferred.
Working knowledge of cGMP, QSR, ISO, SOP’s, work rules and safety guidelines preferred.
2+ years office experience, preferably in a medical device manufacturing organization.
Advanced computer skills in such areas as Excel, Word, PowerPoint, Project, Visio, ERP, and Database Management preferred.
Effective communication skills, both written and verbal.
Must be able to read, write, and fully comprehend English.
Excellent teamwork, communication, and interpersonal skills.
A demonstrated commitment to company values.
Physical requirements
Excellent manual dexterity and eye/hand coordination.
Standing for prolonged periods of time.
Sitting for prolonged periods of time.
Ability to lift up to 30 lbs.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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