Job Description


DOCUMENT CONTROL SPECIALIST 2

Maxonic is looking for a DOCUMENT CONTROL SPECIALIST 2 for one of our leading customers. 

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates.

Benefits offered to our employees include:

  • Medical Insurance through Cal Choice [Kaiser and Anthem Blue Cross]
  • HSA (Health Savings Account)
  • 401K Plan
  • Paid Sick Time Off

JOB DESCRIPTION:

  • 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 

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 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

Position logistics:

  • Candidates must be currently authorized to work in the US for any employer
  • 11-12 months Contract position
  • Sunnyvale, CA

Interested in Applying?

We can’t wait to see your resume! Please apply below with your most current resume and anything else you’d like us to know about you – commute preferences, desired work environments, etc. You should also feel free to email Amit Kumar (amit.k@maxonic.com) or call 408-715-1210 Ext 103