Document Control Specialist
Intuitive Surgical 28 reviews - Sunnyvale, CA

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Job

:

Clinical / Regulatory

Primary Location

:

United States-California-Santa Clara County-Sunnyvale

Schedule

:

Full-time

Document Control Specialist

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120631

Description

Primary Function of Position:
The Document Control Specialist is responsible for 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).

Roles and 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

Provide guidance and communication to Originators in order to share best practices and resolve change issues and/or 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

Manage/participate in projects/assignments that support continuous improvement efforts and department/company goals

Qualifications

Skill/Job Requirements

Minimum requirements in order to adequately perform the responsibilities of this position

Education

High school diploma

Two years college, however four year college degree is preferabl

Experience

3+ years of experience working in Document Control in a Regulatory or Quality organization with a minimum of 2 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

Skills

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

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

About this company
28 reviews
Intuitive Surgical is haptic to meet you. Employing haptics (the science of computer-aided touch sensitivity), the firm developed the da...