The Document Control Specialists is responsible for managing company documents while also ensuring their accuracy, quality and integrity. This position ensures adherence to record retention policies, safeguard information and retrieval of data more effectively. This position will strengthen the company’s Quality System efforts by providing support to ensure our customers receive the highest possible quality products. This will be achieved by working with the Quality management team to support Documentation control and Training.

Responsibilities:

  • Intakes documents to include blueprints, drawings, change orders and specifications that are approved by Engineering.
  • Create and modify components and assemblies in ERP, BOM (bill of material) and operation structure.
  • Works closely with Engineering and Quality regarding any changes or discrepancies that are found.
  • Responsible for maintaining and distributing the documents.
  • Process ECO’s (engineering change orders), rework reports, problem reports, deviations and ensures all changes to production related documentation are communicated clearly through the ECO process and related SOE’s.
  • Responsible for tracking, trending and reporting on status of Document control activities.

Requirements: 

  • Minimum of 3-5 years’ experience in Quality Assurance working in a ISO regulated environment
  • Experience in a medical devices environment preferred
  • Knowledge of FDA/QSR regulations
  • Knowledge of ISO 13485:2012
  • Knowledge of ISO 14971:2012
  • Bachelor degree preferred
  • Excellent communication and written skills
  • Strong operations and computer systems exposure
  • Proficient in Microsoft programs word, excel, outlook, PowerPoint, etc.
  • Must be well organized and detail oriented with the ability to meet deadlines

What to do Next:
Please reply to this posting with your resume attached as a Word Document. If your resume is selected, be prepared for an internal interview as soon as possible, so that we can assess your skills and experience. APPLY TODAY!

 

 

 

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