Description : Complaint handling specialist. Company : Thermo Fisher Scientific. Location : 754 50 Uppsala

Job Description

Thermo Fisher Scientific is the world leader in serving science, with annual revenue exceeding $40 billion. No other company can match our range of customer touch points - technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.

This position is based in Uppsala, where Thermo Fisher develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,900 employees worldwide, and 1,000 in Sweden, we are the global leader in in-vitro allergy testing and the European leader in autoimmunity diagnostics.

How will you make an impact?

We are looking for a Complaint Handling Specialist to be part of our Product Quality Management team. The essential tasks for the team are to ensure that Complaints and Field Actions are executed in a compliant and timely manner, with patient, customer and safety in focus. This position maintains, develops and measures the Complaint and Field Action processes to ensure compliance and internal KPI´s.

As Complaint Handling Specialist you will work in a cross-functional environment, with Quality Management in Freiburg, the R&D teams, Operations, Global Service and Commercial Operations. You will be expected to drive and implement improvements and a successful candidate will show attitude and examples showcasing that continuous improvement comes naturally.

What will you do?

• Chairman of the Complaint board
• Responsible for handling of customer Complaints according to procedure
• Responsible for handling of Vigilance activities
• Responsible for handling of Field Actions
• Responsible to provide User training for processes and IT systems used
• Establish and monitor KPI/PI for the processes and providing reports to senior management
• Be an active business partner to the Commercial Organizations, including the customer service and support teams
• Support and follow-up CAPA´s related to Field Actions and customer Complaints
• Participates in team projects and assignments, facilitating or leading teams as necessary
• Identifies the opportunities for continuous improvement of the Quality Systems
• Provide Quality System expertise to the organization and ensure compliance to applicable Quality System Regulations by supporting interpretation of regulations, performing gap analysis and lead activities to implement improvements
• Support investigations and resolve Quality System non-conformities (defined during internal and/or external audits)

What will you need?

• A university degree in medical/technical sciences or a minimum of 5 years in a medical regulated industry or similar experiences
• Experience from quality management systems in an IVD/Medical device environment, e.g. QSR, EU medical directive, ISO 13485, ISO14971, etc.
• Excellent verbal/written communication skills; fluent in Swedish and English
• Strong Leadership capabilities, process and customer focused
• Strong interpersonal skills, driving cross-functional collaboration
• Ability to organize work, can decide about and reach objectives for the processes
• Strong analytical problem solving skills
• Strong ability to drive tasks/projects to closure in a timely fashion
• Experience of working in an international organisation and be used to building long term strategies related to Quality
• Knowledge about the IDD product portfolio, preferably with a R&D background is meritorious

Please apply as soon as possible.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.