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Documentation Control Specialist- Med Device- Santa Clara, CA

Company: Real Staffing
Location: Santa Clara
Posted on: November 25, 2022

Job Description:

Medical Device (Robotics) - Document Control Specialist Duration: 6 Month ContractVacation Time: eligible to accrue up to 2 weeks of PTO annuallyHolidays: 9 paid holidaysKey Responsibilities:

  • Facilitate the change control process from initiation through all workflows steps to implementation including review of completed change orders for content and the approvals.
  • Collaborate and provide mentorship to change owners, approvers, and business partners.
  • Review change orders and items for completeness and compliance with QSR, ISO and internal template and procedure requirements in a timely manner.
  • Perform final incorporation of documentation revisions and pre-release preparation of the document files associated with approved change orders and ensure workflow activities are completed.
  • Consult with end users regarding problems in accessing electronic content
  • Select and/or verify required approvers of changes per procedures.
  • Assist in the preparation of document control metrics and reports, including but not limited to periodic review process and change order timeliness
  • Communicate the status of changes.
  • Support and recommend change control process improvements including initiating procedural revisions.
  • Support both internal and external audits, as well as quality events (CAPA, NC, Audit findings), relating to document/change control processes.Seeking:
    • Proficient in Microsoft Suite (Outlook, Word, Excel, and PowerPoint)
    • Experience with Product Lifecycle Management (PLM) systems, such as Agile PLM, ADAPTIV (Enovia platform), Windchill, and/or equivalent PLM systems within a regulated industry
    • Familiarity and ability to apply Good Manufacturing Practices (GMPs) documentation requirements, especially pertaining to quality records and change control
    • Medical Device, Pharmaceutical, and/or Biotech experience
    • An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to document control, training, quality records, and process control is preferred.
    • Experience with MRP/ERP systems such as SAPEOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Keywords: Real Staffing, Santa Clara , Documentation Control Specialist- Med Device- Santa Clara, CA, Other , Santa Clara, California

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