Market Surveillance Specialist (Temporary position)
Werfen is a growing, family-owned, innovative company founded in 1966 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 7,000 strong.
Overview
The role involves managing customer complaints received via mail and SAP system, performing necessary testing, and providing timely responses. Responsibilities include preparing department metrics, reviewing notifications from official agencies, participating in the annual Post Market Surveillance Plan, and maintaining documentation and communication with customers and internal departments.
* Open complaints in SAP, assign complaint numbers, and notify customers.
* Gather missing information by following up with customers, and archive all communications and documents.
* Receive patient samples and kits for investigation.
* Coordinate consultations and verification procedures with relevant departments.
* Perform tests to investigate complaints and review customer-provided backups.
* Inform Quality Operations Director of investigation results and prepare final reports.
* Send reports to customers and document all activities in SAP.
* Archive documentation once complaints are closed.
* Review and circulate notifications from health agencies.
* Monitor department metrics and prepare Post Market Surveillance reports.
* Generate monthly complaints summaries.
Internal Networking
* Collaborate with Regulatory Affairs, Quality Control, Marketing, Production, Filling and Packaging, Customer Service, and Technical Support departments.
* Coordinate with other departments based on the complaint and product involved.
* Maintain relationships with external customers.
Qualifications
Minimum Knowledge & Experience
Degree in Science or Health-related field (Ciclo Formativo de Grado Superior), with laboratory experience in chemical, biological, or health-related areas.
Valuable: Additional higher degrees.
Experience
At least 2 years in a similar role.
Knowledge
Office tools (Excel & Word), basic SAP knowledge, fluency in Spanish or Catalan, and intermediate English skills.
Familiarity with Quality Management Systems.
Skills & Capabilities
* Practical technical skills and problem-solving abilities.
* Proficiency with technical equipment calibration and use.
* Effective time management for multiple projects.
* Flexibility and teamwork skills.
* Experience in technical reporting and demonstrations.
* Strong communication skills.
* Alignment with Werfen's values in work quality and relationships.
Travel Requirements
Not required
What we offer
* A meaningful project impacting laboratory medicine worldwide.
* Multicultural and friendly team environment.
* Ongoing training opportunities.
* Social benefits: Canteen, nursery check, training, private medical insurance, retirement plan.
If you are eager to learn and face daily challenges, we encourage you to submit your resume or CV.
Werfen values diversity and is an Equal Opportunity Employer M/F/D/V.
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