Document Control Specialist 3

Job Description
Position : Document Control Specialist
Location: Sunnyvale, CA (Hybrid)
Duration: 12+ months of Contract (High Possibility of extension)
Job Title: Document Control Specialist 3
Primary Function of Position:
The Document Control Specialist is responsible for assisting the Document Control lead and manager in maintaining and continuously improving the Document Control Quality System in order to support the business and release of marketed products, meet regulations and established requirements. Ensures that product and product related documents are processed through the Agile database in compliance with established procedures, Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Deviations and Engineering Change Requests (ECRs). This role requires sedentary and repetitive working conditions.
Roles & Responsibilities:

• Process documentation changes in Agile: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectives
• Audit changes for accuracy and completion. Review changes to ensure that language used in the change is adequate and in compliance. Ensure that changes are in a closed loop and all discrepancies (if any) are addressed and closed before the change is released
• Provide clear and accurate communication to internal customers. Clearly communicate both verbally and in writing, with Originators when discrepancies are found. Give precise guidance to originators for the proper process to follow when to correct issues/discrepancies.
• Provide Agile and change procedure training support as needed to co-workers within and outside Document Control
• Promptly respond to questions and issues raised by Originators and Approvers
• Work with ECO Coordinator to select changes for CCB meetings based on production impact
• Represent Document Control at CCB meetings
• Work with ECO Coordinator and Originators in following up, analyzing and helping to resolve open ECO/MCO issues
• Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals
• Familiarity with Design History requirements and documents
• Experience with and, clear understanding of the Quality System Regulations and ISO 13485 requirements
• Lead/participate in projects/assignments that support continuous improvement efforts and department/company goals
• Provide change control training (processes and system) to users
• Maintain change control training materials up to date
• Create and maintain change control metrics and reports

• High school diploma
• College degree is preferable

• 5+ years' experience working in Document Control in a Regulatory or Quality organization with a minimum of 3 years at medical device company
• Experience processing changes using an electronic documentation system
• Proficient using Word and Excel applications, and Windows operating system
• Experience using Agile

• Must be able to work effectively in a fast paced, team-oriented environment
• Ability to work independently with minimal supervision
• Demonstrated ability with database applications. Proficient using Word and Excel application, and Windows operating system
• Demonstrated cross-functional teamwork skills
• Self-starting, detailed oriented, and ability to focus on task at hand
• Ability to work independently with multiple departments to resolve Document Control issues
• Well-developed English written and verbal communication skills