Temp position - RAQA Specialist - 29765BR - FR in Pusignan at Stryker Corporation

Date Posted: 4/9/2018

Job Snapshot

Job Description

Ownership of the Post Market Activities for Physio Control products:

1/ Complaints handling

  • Raising complaints in a timely manner in CHS (Complaint Handling System)
  • Communicate by phone or emails with external customers in order to report the events appropriately and get the information required for the investigation of the products.
    Following up on open PERs to ensure an effective and efficient complaint investigation can be perfomed. Obtaining appropriate supporting information from the customer and Stryker Staff including ensuring customer needs are understood
  • closing PERs - Preparing closure letters for customers where appropriate.
  • closely work with operations staff in order to get the affected products shipped back to manufacturer for investigation purposes
2/ Management of product holds and Regulatory Actions (PFA)
  • Ensure the blocking / unblocking of the devices impacted by a product hold or a PFA in the ERP System upon Legal Manufacturer request
  • Ensure the products and the customers impacted by a hold or a PFA are properly identified
  • Require products quarantines and product releases relative to PFAs and 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 holds with the support of the other involved Departments
  • Ensure that all PFA and Holds are communicated to the local business and key stakeholders
  • Carefully monitor the follow-up of PFAs and 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 Holds in line with Corporate and EU Policies.

Job Requirements

Graduated at minimum with a Degree
• Fluent in English and French
• Successful work experience in a Customer Complaints Dpt ideally in the a Medical Device/Pharmaceutical company
• Experience in MD vigilance or Post Market Surveillance activities highly desirable
• IT literate, particularly Microsoft Suite ; knowledge of Trackwise and Oracle desirable
• Team working skills
• Strong communication skills, both oral and writing
• Customer orientated
• Proactive mindset, problem solving oriented
• Ability to prioritise and organise own workload
• Accurate, rigourous and conscientious
• Working to strict deadlines and under pressure


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