Market Surveillance Specialist (Temporary Role)

Job Summary
Manage the complaints received from our customers via mail and SAP system perform the necessary testing in order to send a timely response to the customer. Preparation of the Departments metrics review of the Notifications of the Official Agencies and internal notifications as applicable and preparation and participation in the annual Post Market Surveillnce Plan.

Key Accountabilities

• Receive and manage complaints through address and archive them.

• Open the complaints in SAP system which will assign the complaint number.

• Notify the customer that their complaint has been received and inform them of the complaint
  number assigned.

• Find out if there is missing information in order to initiate the complaint by following up with the customer. Archive all the communications and documents attached via mail and in paper format with all the documentation of the complaint in question.

• Receive the patient samples and kits used by the customer as needed to perform the
  investigation.

• Initiate all the necessary consultation and verification procedures individually or with other departments to give a response to the open complaint.

• Perform as needed the necessary tests to investigate the complaint.

• Review the backup of the complaint provided by the customer if applicable.

• Inform Quality Operations Director of the results obtained in the investigation and prepare the preparation of the final report for the customer.

• Send the final report to the customer via mail.

• Register in SAP all the results of the tests and activities performed during the investigation
  of the complaint.

• Once the complaint is closed in SAP archive all the documentation.

• Review the Notifications from the Health Agencies and circulate those applicable internally.

• Monitor Departments metrics.

• Preparation of the Post Market Surveillance reports for the products involved and follow up and perform changes if applicable.

• Preparation of the Complaints Summary and a monthly complaints summary.
  

Internal Networking

To be determined based on department needs to include interactions such as:

• Directly relationship with Regulatory Affairs Quality Control Marketing Production Filling and Packaging Customer Service and Technical Support departments.

• Relationship with the remaining Departments according to the complaint and according to the product involved.

• General relationship with the customers.

Minimum Knowledge & Experience required for the position

• Degree/studies

  • Required: Ciclo Formativo de Grado Superior in Science or Health-related field
    completed with experience in chemical biological or health-related laboratory

  • Valuable: Any additional degree higher than that required in the previous section

• Years of experience

  • Minimum of 2 years in a similar role

• Min knowledge

  • Software: Fluency in Office Tools (Excel & Word) Valuable Basic knowledge in SAP.

  • Standard: Quality Management Systems.

  • Language: Fluency in Spanish or Catalan. Medium knowledge of English (reading and
    speaking).

Skills & Capabilities

The ideal candidate for this position will exhibit the following skills and competencies:

• Ability to learn specific practical techniques and apply this knowledge to solve technical problems

• Ability to maintain calibrate and use technical equipment with accuracy.

• Time management skills to work on several different projects at the same time.

• Flexibility to work with and provide support for a number of people.

• Experience in providing demonstrations and writing technical reports.

• Teamwork and interpersonal skills.

• Attention to detail.

• Oral and written communication skills.

• Reflects values of Werfen in the quality of work and working relationship.

Travel Requirements

Not required