Description:

The Document Control Specialist will ensure that all device history records produced by Cogmedix meet defined expectations. This includes the resolution of all discrepancies found during the review prior to approval of the device history records and subsequent release of product. In additional the Document Control Specialist will support all activities related to the control of Documents and Records maintained by Cogmedix.

Responsibilities:

The Document Control Specialist position will have an area of excellence that will focus on primary responsibilities e.g. inspection, test, document control, CAPA etc. Each Document Control Specialist will also cross train in other areas of the quality organization to strengthen core competencies as a Quality Associate.

Supports Quality management to achieve Quality Department objectives and goals by providing administrative assistance.

Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO13485 requirements.

Understands and follows good documentation practices in a cGMP and ISO 13485 environment.

Organizes and reviews Device History Records (DHR’s) at the completion of the manufacturing cycle and ensures all signatures and data are present prior to final approval. Scan DHR’s, save electronically, and upload to FTP sites.

Assists Quality management with the creation, update, and processing of new and existing procedures, work instructions, and all other Quality department documentation.

Update Quality Manuals as needed.

Training

Assists in the development and maintains associate training curriculum, which consists of documentation, training records, training matrix and materials.

Prepares 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.

Assists in the administration of Corrective and Preventative Actions, as required.

Assists in coordinating and preparing monthly Quality Metrics as well as metrics needs for Management Review.

Assists in the entry of Non-conformances, Customer Complaints, and other Quality items within the respective Quality Databases.

May help coordinate Customer Satisfaction Surveys.

Maintains the Quality System Documentation Control System including the Master List.

Performs all Quality Department administrative functions as required.

Assists with all Notified Body, FDA, Internal and/or customer audit related activities.

Scan Design History Files (DHF), to save electronically and upload to customer FTP sites.

Enter documents into electronic systems including BOM, part creation and documents, work instructions, uploading drawings and procedures.

Initiates Change Orders electronically.

Coordinates 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.

High School Diploma or GED required, some College education preferred.

Working knowledge of cGMP, QSR, ISO, SOP’s, work rules and safety guidelines preferred.

2+ year’s office experience, preferably in a medical device manufacturing organization.

Advanced computer skills in such areas as keyboarding, MS Excel, MSWord, MS PowerPoint, MS Project, ERP, Internet, & Database Management beneficial.

Effective communication skills, both written and verbal.

Must be able to read, write and comprehend English.

Excellent teamwork, communication, and interpersonal skills.

A demonstrated commitment to company values.

Cogmedix is an Equal Opportunity Employer. Cogmedix does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.