Document Control Specialist

The Document Control Specialist is the expert in maintaining control of all Quality Management System documentation and training with respect to medical device regulations and business objectives. All Document Control functions must be compliant with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality Management System Requirements (QMSR), Medical Device Single Audit Program (MDSAP), and other applicable regulatory requirements. This position is responsible for organizing, maintaining, and updating all controlled documents and ensuring training is executed in a timely manner.

The Document Control Specialist collaborates with all departments to maintain a compliant program and meet business needs. This position works independently, with minimal supervision, to accomplish daily tasks by efficiently and effectively utilizing the Company's EDMS. The Document Control Specialist will drive continuous improvement within the system and create and maintain metrics regarding document status, priority, change management, training assignment, and training completion.

This position will be the Subject Matter Expert (SME) and provide guidance regarding creation, proof-reading, and accuracy of documents. The Document Control Specialist ensures that Design and Development requirements are met within the processes by review and collaboration with stakeholders.

The Document Control Specialist is the EDMS SME, responsible for managing all aspects of the document control processes, including training.

• Document Lifecycle Management:
  Create, review, revise, and archive Standard Operating Procedures (SOPs), work instructions, marketing documents, technical documents, specifications, and documents of external origin.
• Version Control:
  Maintain precise revision tracking and document history
• Serves as the Master Control System SME and provides training/guidance to all levels of system end-users
• Implement and streamline document workflows
• Maintains training materials, records, and metrics for the various levels of system users
• Prioritizes Change Control activities by compliance and business requirements
• Drives Change Control to completion using metrics and periodic reporting
• Maintains Change Management and Training processes
• Identifies negative data trends and escalates immediately as necessary
• Manages the release and control of updates to policies, procedures, instructions, etc.
• Manages Quality Records and programs including New Hire Training, activating and deactivating employees in the system, electronic and off-site document retention.
• Communicates effectively with cross-functional and external stakeholders
• Manage vendor and customer change control processes
• Assists with external inspections and audits; preparation and timely support during inspections/audits
• Implements best practice solutions to improve and maintain processes
• Manages Deviation process
• Assumes other responsibilities as assigned by functional manager

• Expertise in EDMS systems
• Strong computer knowledge (MS Office)
• Demonstrated initiative and ability to work independently while handling multiple tasks
• Outstanding organizational skills and ability to work systematically and cross-functionally, driving assigned tasks to completion
• Must have strong technical writing and proofreading skills, as well as exemplary attention to detail due to demand for accuracy in controlled documents
• Ability to clearly communicate, both verbal and written
• Good theoretical knowledge with ISO standards and Medical Device Regulations
• Strong focus on internal and external customer service
• Ability to take direction and multi-task in a dynamic environment.
• Ability to work effectively both independently and as part of a team
• High ethics and integrity

• Associate Degree and a minimum of 5 years of hands-on work experience in a regulated industry (medical device is strongly preferred) as a Document Control Specialist.

• Master Control Document System experience
• ISO 13485:2016 Auditor
• MDSAP experience
• Inspection & Audit readiness

• Sitting ~ 75%
• Walking/Bending/Standing/Stooping %: ~25%
• Lifting Requirements