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 Quality Associate will also cross train in other areas of the quality organization to strengthen core competencies as a Quality Associate.
Responsible for following Cogmedix’s Quality Management System, cGMP’s and ISO 13485:2016 requirements.
Understands and follows good documentation practices in a cGMP and ISO 13485:2016 environment.
Organize and review Device History Records (DHR’s) at the completion of the manufacturing cycle and ensure all signatures and data are present prior to Project Manager (PM) and Quality reviewing and sign off.
Assist the Vice President of Quality and Compliance with the creation, update, and processing of new and existing procedures, work instructions, and all other Quality department documentation.
Update Quality Manuals as needed.
Maintain employee training curriculum which consists of documentation, training records, training matrix and materials.
Prepare and deliver curriculum as necessary to support Cogmedix training needs.
Assist in providing Training Plan / Job Description for employees.
File training logs in employee’s folders upon completion of training.
Coordinate training classes when appropriate.
Assist in the development of specific training curriculum.
Assist in the administration of Corrective and Preventative Actions.
Assist in coordinating and preparing monthly Quality Metrics for Management Review.
Assist in the entry of Non-conformances, Customer Complaints, and Service Orders, within the respective Quality Databases.
Help coordinate Customer Satisfaction Surveys.
Maintain the Quality System Documentation Control System including the Master List.
Perform all Quality Department administrative functions as required.
Scan DHR’s, save electronically, and upload to customer FTP sites.
Assist with all TUV, FDA, Internal and/or customer audit related activities.
Coordinate with Vice President of Quality and Compliance on quality problems relating to the product, process and Quality System.
Performs other activities as directed.
Positive attitude, self motivator and tenacious follow up.
Attention to details and superior organizational skills.
Superior customer service attitude.
High School Diploma, some college preferred or equivalent office experience.
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 keyboarding, MS Excel, MSWord, MS PowerPoint, MS Project, ERP, Internet, & Database Management.
Possess knowledgeable general skill in such areas as the phone system, time management, customer communication, and laminating machine, binding machine, data entry and proof reading.
Effective communication skills, both written and verbal.
Must be able to read and write in English.
Excellent teamwork, communication, and interpersonal skills.