DOCUMENT CONTROL

ISO9001 Document Control Specialist

ISO9001 Document Control Specialist is responsible for creating and maintaining documents related to our Quality Manager System in accordance with ISO9001. This role ensures that policies, procedures, work instructions, records, and forms are properly reviewed, approved, distributed, revised, archived, and accessible to relevant personnel. The specialist supports audits, regulatory compliance, continuous improvement initiatives, and document integrity across the organization.

Responsibilities

• Managing our Corrective Action process ensuring all documents are completed in a timely manner
• Photography related to process documentation.
• Managing our Internal Audit schedule and performing Internal Audits
• Maintain and administer the company's document control system for the Quality Management System (QMS)
• Control creation, review, approval, revision, distribution, and archival of documents
• Ensure compliance with ISO 9001 document control requirements
• Track document revisions and maintain accurate version histories
• Coordinate with department managers to update procedures and work instructions
• Ensure obsolete documents are removed from points of use
• Maintain document retention schedules and records management practices
• Support internal and external ISO audits
• Prepare document packages for certification and customer audits
• Train employees in document control procedures and systems
• Monitor document compliance metrics and reporting
• Assist with corrective actions and continuous improvement initiatives
• Ensure confidentiality and security of controlled documents
• Adhere to all employment policies/safety policies/practices required by law/established by Company.
• Immediately report any maintenance and/or safety issues to supervisor.
• Maintain respect, courtesy, a positive attitude and professionalism towards all co-workers and the Company.
• Actively participate and support the 5S process by maintaining a clean workstation and department.
• Other duties assigned as required.

Qualifications & Knowledge

• 2+ years of document control or quality assurance experience
• Working knowledge of ISO 9001 standards and QMS principles
• Strong organizational and recordkeeping skills
• Excellent attention to detail and accuracy
• Proficiency in:
  • Microsoft Office Suite
  • SharePoint
  • Adobe Pro
• Strong communication and coordination abilities
• ISO 9001 Internal Auditor certification (or ability to obtain)
• Experience in manufacturing, medical device, aerospace, biotech, or regulated industries
• Familiarity with:
  • Change control systems

Working Conditions

Work is normally performed in a climate-controlled office environment and throughout a heated manufacturing and warehouse facility. Exposure to conditions of extreme heat/cold, poor ventilation, fumes and gases is very limited. Noise level is moderate and includes sounds of light manufacturing, shipping and receiving, and normal office equipment (computers, telephones, etc.). No known environmental hazards are encountered in normal performance of job duties.

Physical Demands

• Be able to lift objects up to 35 lbs.
• Be able to lift, push and pull objects as necessary
• May be required to stand and walk throughout the workday
• Occasionally required to bend, stoop, kneel and crouch

Monday-Friday 7:00 am to 3:30 pm