Now Hiring: Document Control Clerk

Hourly   ·   Fulltime   ·   Monday – Friday   ·   Bozeman, Montana

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.

Responsibilities:

• 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

Disclaimer

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.

Background / Skills / Experience:

• 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

Qualifications:

• 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

About the Culture

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:

Being a team player. We look for engineers for whom no job is too small. We work together as a team to provide the best possible experience for our customers.

Interested in learning. We want engineers who are curious to understand the how and the why of what they do, who are aware and thinking about how their code interacts with the operating system, and generally interested in the problem space. Our engineers need to be good mentors to their fellow teammates and open to be mentored.

Passion for testing. In our development process, every engineer is responsible for the quality of the product. This requires that everyone is focused on producing code that is easily testable, modular, and correct. As engineers, we are responsible for unit, functional, and system-level testing.
Focus on quality. Neuralynx products are the best in the field, and our customers demand the best. Our engineers are constantly focused on quality, whether it is consumer software, internal utilities, or engineering infrastructure. We desire to work with teammates who won’t hesitate to speak up when they see inefficiencies that can be improved or technology adoptions that can aid in our efforts.

About the Company

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…

About the Location

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.

To Apply…

send a brief cover letter with your résumé/CV to Neuralynx Human Resources: hr@neuralynx.com

Please click here to learn more.