Position Summary:

The Document Specialist is primarily will be responsible for managing and maintaining the company’s documentation related to incoming product inspection, product returns and distributed product management and any products cycling back from the field. 

Essential Duties and Responsibilities:

• Maintaining paper, electronics and database files for Quality and Integrity.

• Organizing large amounts of documents.

• Verifying the completeness and accuracy of stored documents, as well as appropriate formatting completion, filing and maintenance of device history and training records.

• Support and participate in process improvements and perform quality process checks.

• Assist with copies, sorts and filing of records related to office activities.

• Maintain records room and file records as necessary.

• Manage Office Supplies

• Perform Facility Safety and Quality Checks

• Assist in maintaining a clean warehouse to always ensure efficiency and organization.

• Operations assistance as assigned by Quality Manager.

Minimum Qualifications (Knowledge, Skills and Abilities):

Experience/Education:

• HS Diploma

• 1 – 3 years administrative assistant experience.

• 1 – 3 years document control experience.

• Experience in a highly regulated environment is a plus

• Understanding of document control process in accordance with ISO 13485:2016, 21 CFR 820 FDA Quality System Regulations (QSR) and EU Regulations (MDR) is a plus.

Knowledge/Skills/Abilities:

• Exceptional attention to detail.

• Ability to manage an organized workload and prioritize demands.

• Ability to juggle multiple responsibilities simultaneously, stay focused on deadlines and handle complex projects efficiently and have a positive mindset.

• Open communicator willing to present issues along with possible solutions, support and encouragement as the situation arises.

• Computer software knowledge (i.e., Word, Excel, PowerPoint). 

• Proficient Typing Skills.

• Minute taking.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to

successfully perform the essential functions of this position. Reasonable accommodations may be made

to enable individuals with disabilities to perform the functions.

Working Conditions/Hours:

• Full time: May be required to work hours in addition to 8am -5pm, Monday – Friday in the instance of audits and other scheduled activities related to the business Quality Management System.

Physical Demands – Office

While performing the duties of this position, the employee is regularly required to talk or hear. The

employee frequently is required to use hands or finger, handle, or feel objects, tools or controls. The

employee is required to stand; walk; sit; reach with hands and arms and pull/push; climb or balance; and

stoop, kneel, crouch, or crawl. The employee must lift and/or move up to 50 pounds without assistance.

Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus.

Work Environment – Office and/or Remote

This job operates in a professional office environment with minimal exposure to dust, chemicals or

noise. This role routinely uses standard office equipment such as computers, phones, photocopiers,

filing cabinets and fax machines.

Compensation:

• $25.00/hr - $30.00/hr

• Comprehensive benefits 

• Paid time off and holiday policies

We are proud to be an equal opportunity employer and will consider all qualified applicants for employment. 

Note

This job description in no way states or implies that these are the only duties to be performed by the

employee(s) incumbent in this position. Employees will be required to follow any other job-related

instructions and to perform any other job-related duties requested by any person authorized to give

instructions or assignments. All duties and responsibilities are essential functions and requirements and

are subject to possible modification to reasonably accommodate individuals with disabilities. To perform

this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty

proficiently. The requirements listed in this document are the minimum levels of knowledge, skills, or

abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

You should also note that the Company may modify job title, pay rate, work location and benefits at its

discretion from time to time as it deems necessary.