Document Control Specialist II

The Document Control Specialist II maintains control of all quality documentation.

This position works independently, with minimal supervision, in accomplishing daily tasks and advising others.

This position works closely with all departments to maintain a compliant program.  This position is responsible for organizing, maintaining, and updating all controlled documents.

All functions of the document center must be in compliance with quality system GMP, 21 CFR 820 (FDA), ISO 13485 and other quality standards.

This position actively and independently leads projects with minimal support within established deadlines and expectations.

The Document Control Specialist II:


* Processes, releases, and Controls Engineering Change Orders.


* Responsible for creating part numbers and Bill of Materials (BOMs) in the ERP system.


* Processes, maintains, and monitors deviations


* Processes, releases, and Controls all Quality documents (e.g.

Standard Operating Procedures (SOPs), Risk Management Documents, Technical Documents, etc.) supporting the lifecycle 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 service, and management.


* Writes, creates, updates, and submits Quality SOPs, Forms, Templates and other Quality documents for review and approval.


* Leads Document Control Quality projects and drives the projects to completion within established deadlines.


* Identifies continuous improvements in Document Control processes and drives and implements those improvements.

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Archives obsolete and historical documents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 service and business needs.
11.

Key stakeholders include but not limited to, Quality, Engineering, Purchasing, Marketing, Regulatory, Customer S...