Document Control Specialist - Temporary/Short-Term - On-Site - 40 Hours/Wk. Mon.-Fri.

Document Control Specialist - Temporary/Short-Term - On-Site - 40 Hours/Wk. Mon.-Fri. - DOCUM...1

DESCRIPTION/RESPONSIBILITIES:The Document Control Specialist: * Processes, releases, and Controls Engineering Change Orders. * Processes, maintains, and monitors deviations. * Processes, releases, and Controls all Quality documents (e.g. Standard Operating Procedures, Risk Management Documents, Technical Documents, etc.) supporting the Lifecyle of product documentation. * Manages the calibration of all calibrated equipment and ensures all calibrated equipment is within specification and certification, as required, is maintained. * Supports the Head of Quality to establish and maintain Quality Systems in a compliant manner. * Interacts with manufacturing and design engineering, quality regulatory, marketing, customer care, and management.

Essential Duties:1. Promotes a work environment of continuous improvement that supports CQ Medical's Quality Policy, Quality System, and the appropriate regulations.2. Assists with communicating business related issues or opportunities for improvement to management.3. Accountable for document control compliance with applicable US and International regulations and directives including, but not limited to, Food & Drug Administration (FDA), Canadian, and EU MDR regulations.4. Assists with creating, editing, and proofreading documents.5. Maintains Document Control systems.6. Archives obsolete and historical documents.7. Creates and maintains part numbers and Bill of Materials in ERP/MRP system.8. Monitors training history documentation.9. Works in a team environment to achieve metrics and business goals.10. Collaborates with engineering and other stakeholders to process Engineering Change Orders in a timely manner for optimal customer care and business needs.11. Key stakeholders include but not limited to, Quality, Engineering, Purchasing, Marketing, Regulatory, Customer Care, and Manufacturing.12. Leads and maintains the Layered Process Audit program.13. Supports management review and all audits/inspections.14. Maintenance of Quality procedures.15. Administrates the Calibration program.16. Assists with CAPAs related to Document Control.17. Assists with internal audit program.18. Identify Continuous Improvement.19. Remain current on all required training.20. All other job functions as assigned.

Working Conditions *