RAQA Specialist in Roma at Stryker Corporation

Date Posted: 2/17/2020

Job Snapshot

Job Description

  • Ensure the blocking / unblocking of the devices impacted by a Commercial Hold or a PFA in the ERP System upon Legal Manufacturer request
  • Ensure the products and the customers impacted by a Commercial Hold or a PFA are properly identified
  • Require products quarantines and product releases relative to PFAs and Commercial Holds
  • Notify the customers impacted by a PFA and answer to all associated queries
  • Ensure the final lot reconciliation. Take any appropriate action to solve the discrepancies related to PFA and Commercial Holds with the support of the other involved Departments
  • Ensure that all PFA and Commercial Holds are communicated to the local business and key stakeholders
  • Carefully monitor the follow-up of PFAs and Commercial Holds initiated in France up to closure
  • Provide reporting as appropriate to local management and Legal Manufacturer when required
  • Implement and maintain local documentation (procedures, working instructions, training support) related to PFA and Commercial Holds in line with Corporate and EU Policies.
  • Responsible to monitor and run Product Complaint Handling Process
    • Raising and closing PERs in a timely manner.
    • Preparing closure letters for customers where appropriate.
    • Following up on open PERs to ensure an effective and efficient complaint investigation can be performed.
    • Obtaining appropriate supporting information from the customer and Stryker Staff including ensuring customer needs are understood.
  • Facilitate information flow with Stryker Division regarding technical information and medical assessments
  • Provide adequate trainings to other departments and any new on board
  • Prepare regular reports as requested: weekly / monthly reports, support quality management meetings and audits preparation and readiness
  • Complete and follow up on actions relating to internal processes in accordance with Company targets, procedures, policies and standards.
  • Active member of EMEA PER team, providing support to colleagues and working towards streamlined, harmonized, best practice PER process across EMEA. 

Work From Home: Regularly scheduled days

Travel Percentage: 10%

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