Reports to the Vice President RA/QA
The Document Control Clerk will be responsible for processing Quality Management System (QMS) documents and maintaining the document control system in the electronic QMS. Also responsible for scanning and filing records, including training files. Other duties may be required as necessary to support the QMS.
Maintaining QA records according to applicable regulatory requirements and Neuralynx policy
Modifying and formatting documents according to Neuralynx guidelines
Scanning and filing of hard copies and digital records into the QMS
Managing Change Orders for documents in the electronic QMS document control system
Collecting and maintaining training records
Supporting product development in the preparation of Design History File and Technical Files for regulatory bodies
Maintaining and improving the document control system
Support electronic QMS processes including Corrective/Preventive Actions, Non-conformances, Engineering Change Orders, and Internal Audits
Supporting various aspects of the Regulatory Affairs / Quality Assurance function
Other duties as perceived and agreed upon by management
The above listed duties of the Document Control Clerk are not all encompassing as to the total responsibility of the job. Time spent on tasks other than those listed in this job description are not to exceed 20% of his/her activity. He/She will recognize that common sense rules in all actions, interfaces, and relationships within the department are his/her responsibility. He/She needs to recognize problems, issues and anything else within the Company that does not allow his/her department to run smooth or that interferes in his/her department’s ability to fully fulfill their responsibilities. His/her fiduciary responsibility is to the company and he/she are required to fulfill this responsibility at all times.
Two years of related experience in document control systems, quality systems or similar experience
Two years Quality Assurance experience in a regulated industry with preference for medical device or pharmaceutical product development
Effective communication and interpersonal skills
Knowledge of ISO 13485 and FDA cGMP, QSR regulations
Experience in preparing various types of documentation including SOPs and quality records
Word processing and spreadsheet knowledge, especially MS Word
Ability to perform Internal Audits on QMS modules
Strong organization skills and high attention to detail
Ability to operate in a changing environment
Here at Neuralynx, we value the engineering culture and work hard to maintain a productive and happy work environment. We encourage our engineers to learn, grow, and apply their passions to their daily job. The attributes that we look for include:
Neuralynx is an industry pioneer and leader in neuroscience electrophysiology research tools: specialized, customizable hardware and software data acquisition systems used to measure neural signals down to the individual nerve cell activity!
Neuralynx supports over 1,000 Data Acquisition Systems worldwide – at universities, research institutions, and hospitals, including MIT, UCLA, Mayo Clinic, Yale Medical Center, University of Bonn, Max Plank Research Institute, and RIKEN Research Institute.Read more about us...
Neuralynx is located in beautiful Bozeman, MT. Bozeman offers excellent outdoor activities and sports such as skiing, hiking, fishing, hunting, mountain biking and running. Housing is affordable with a moderate cost of living, and the people are friendly and honest.