MARKET SURVEILLANCE SPECIALIST (TEMPORARY POSITION)

Introduction Werfen is a growing, family-owned, innovative company founded in in Barcelona, Spain.
We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.
Through our Immunoassay business line, we research, develop, and manufacture customized assays and biomaterials.
We operate directly in 30 countries, and in more than 100 territories through distributors.
Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than strong.
Overview 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 Department’s metrics, review of the Notifications of the Official Agencies and internal notifications as applicable, and preparation and participation in the annual Post Market Surveillance Plan.
Responsibilities Key Accountabilities Receive and manage complaints through oem-  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 Department’s 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 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 external customers.
Qualifications 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.
Language.
Fluency in Spanish or Catalan.
Medium knowledge of English (reading and speaking.
Standard.
Quality Management Systems Skills & Capabilities 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 What we offer A meaningful project that will impact the quality of laboratory medicine worldwide Multicultural and friendly team Exciting opportunities for professional development.
Ongoing training Social benefits.
Canteen, nursery check, training, private medical insurance, retirement plan   If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity.
We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
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erfen.
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