DOCUMENT CONTROL

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
• Cookordination 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
• Aid 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

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

Work 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
• Occasionally required to bend, stoop, kneel and crouch
• Monday-Friday 7:00 am to 3:30 pm