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Quality Integration Specialist
Ref No.: 18-09609
Location: Irvine, California
Position Type:Contract
Start Date: 08/03/2018
Summary: This position has the following responsibilities to provide project management support to drive delivery of project goals/schedule established in the Cerenovus Quality integration Plan.

Quality Integration Specialist to drive
  • Non-conformance
  • Material and Product Control
  • Calibration/ Preventive Maintenance
  • Production Process Controls and Final Release
  • Handling, Storage and Distribution
  • Facilities, Utilities and Equipment
  • Identification and Traceability

Responsibilities include:
  • scheduling Program and Workstream team meetings
  • preparing analytics and presentations
  • publishing meeting minutes, follow-up
  • working with Workstream teams to plan activities
  • track completion of tasks and facilitate resolution of issues
  • escalate issues to management as needed
  • review of documentation and provide feedback
  • facilitation of document reviews and approvals
  • Interact with Client, Codman Neuro, and other Cerenovus company Document and Records management teams/systems to ensure all appropriate documentation that requires obsolescence/revision are identified for each integration element to ensure Change requests properly address all affected documentation and Client and Cerenovus Quality systems are properly maintained.
  • Provide strategies for change management tasks to ensure accuracy/efficiency. Assist with Change requests as needed.
  • Assist with identification of training requirements and training implementation.
  • Perform assigned Quality System procedure gap assessments.
  • Perform other tasks as assigned

  • A minimum of a Bachelor's Degree with at least 4 years of clinical or related technical experience required.
  • A Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
  • Strong written and oral communication, planning, organization, analytical and interpersonal skills.
  • Strong knowledge of Microsoft Word, Power Point, Excel. Knowledge of regulations pertaining to medical devices.
  • Experience in FDA/EU regulated business environment, project management, change management, Quality Systems, auditing, document management software.
  • Experience working in the medical device field is a plus