Amick Brown is seeking an experienced Document Control Specialist 3 for our direct client. Location: Sunnyvale, CA Duration: 12 Months Estimated pay range: $ 40 - $ 50 an hour per client contract and candidate skills, experience and work location.
The Document Control Specialist 3 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
Required Skills Education
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
Product Lifecycle Management (PLM) Processes and System
Change Control Management
Quality System Regulations
ISO 13485 2016
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits: