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Document Control Specialist II

San Diego, CA

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Description

Remx is currently hiring several Document Control Specialists for a top Medical Device Manufacturing company in San Diego.

 

Must have medical device / FDA background

Salary is DOE

  

DC Specialist will perform the following duties:

  • Reviews and analyzes proposed changes to identify deliverable, supporting data and approval requirements
  • Facilitates the Change Control Process in the Change Control system
  • Audits, receives, files, and maintains centralized documentation archiving system of controlled quality system documents
  • Receives, classifies, files, audits, tracks and maintains centralized documentation archiving system of controlled Quality System documents according to established procedures.
  • Help in the preparation of the legacy documents for migration into the electronic document control system
  • Commitment to the development, implementation, and effectiveness of company Quality Management system (QMS) per ISO, FDA, and other regulatory agencies

Job Requirements

  • 3 plus years of Document Control experience in FDA environment
  • Must have medical device manufacturing background
  • Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
  • Experience in Change Orders and Change Control Systems:  SAP, Agile, others.
  • High School Diploma / GED

 

Forward resumes for interview consideration.  Company is moving quickly on qualified candidates.

Apply Now