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Senior Document Control Specialist

Position Summary:

The desired candidate will have prior senior-level Documentation Control experience in Quality, preferable working in a medical device company. Specific experience and responsibilities will include, but not limited to: ensure review and storage of all associated Quality documentation related to production, inspection, and shipping of product; manage the change control system; and manage the training system.

 

Essential Function / Major Responsibilities:

  • Responsible for ensuring compliance to all applicable procedures and regulations
  • Ability to maintain electronic documents such as: Validation Reports, Design History files, Manufacturing Transfer Records, and Risk Management files
  • Direct production related tasks for the Document Control group
  • Responsible for maintaining and sustaining the Company’s change control, training and documentation processes and supporting all related activities in accordance with Spectra Medical’s procedures and applicable regulations
  • Manage the change control system, review and release change orders, as required
  • Responsible for document maintenance and storage
  • Monitor status of in-process document changes to ensure timely revisions
  • Create/update custom labels for packaging
  • Assist with prep for quality audits
  • Other Documentation Control tasks, as required

 

Desired Skillset:

  • Bachelor’s degree, preferably in a Quality discipline
  • 3-5 yrs in a medical device quality role
  • Excellent organizational, verbal, written communication and problem solving skills
  • Possess above-average interpersonal skills demonstrating the ability to work in a professional, positive and collaborative manner
  • Ability to work in a fast-paced environment and to meet tight deadlines
  • Willingness to learn, possess a can do attitude, and motivated to succeed and grow
  • Ability to multi-task with strong attention to detail
  • Proficient in MS Office Suite; MRP/ERP systems (preferably NetSuite); document control systems (preferably DocStar)
  • Experience working in a start-up environment, helpful

 

 

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