武汉招聘

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 QMS document,DHF,DMR documents management

• 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

   

   

  Skill/Job Requirements

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

• Education

   

• three years college

   

• Experience 

• 5+ years of 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

   

• 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

Intuitive Surgical is the global leader in the rapidly emerging field of robotic-assisted minimally invasive surgery with presence in more than 60 countries around the world.
  
Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd. is the Joint Venture between Intuitive Surgical and Fosun Pharma- a subsidiary of Fosun International, a leading Pharma and Medical Device Company in China.
  
The intent of the Company is to research, develop and manufacture innovative, robotic-assisted catheter-based Medical Devices.