DOCUMENT CONTROL SPECIALIST 2

Sunnyvale, CA 94086

Posted: 06/15/2019 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 6395

 

Our client manufactures and markets robotic products designed to improve clinical outcomes of patients.

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 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).

 

Role 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

 

Education
  • Education High school diploma
  • Two years college, however four-year college degree is preferable

 

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

Education

  • Education High school diploma
  • Two years college, however four-year college degree is preferable

 

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
Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.