Document Control Specialist

JOB SUMMARY

Manage, administer, and improve the Document Control system at Microline, including but not limited to managing document control, deviations and training.

The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

• Continually explore and learn Microline’s Electronic Quality Management System (eQMS) and teach others to use it
• Review high volumes of data and process ECNs, deviations and training items in eQMS
• Investigate discrepancies and/or missing information or documents
• Review and approve key document control and training workflows for compliance and clarity
• Review system status and prompt users to complete open items as needed
• Participate in continual improvement efforts related to QMS processes
• Manage manual data transfers between the eQMS system and other systems (e.g. ERP system)
• Manage paper documentation and records as required for non-electronic systems (e.g. Device History Records and training records)

In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

• Good written and verbal communication skills.
• Attention to detail is very important
• Ability to learn new operating systems
• 3-5 years of experience in Document Control and/or Change Control, preferably including familiarity with engineering changes, bills of material, procedures, ERP systems, and engineering drawings
• Proficiency with Microsoft Office tools.
• Experience with Solid Works and Solid Works PDM
• Familiarity with ISO 13485, ISO 9001, or other quality system standards
• Experience and comfortable with eQMS and ERP software, ideally Propel and Sage, but including Agile, Windchill, Trackwise, or similar systems
• Experience working in a production environment

Microline is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.