Complaint And Capa Manager Uppsala - Sweden
Thermo Fisher Scientific / Organisationsutvecklarjobb / Uppsala
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As the world's leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than USD 17 billion in annual revenue. 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.
COMPLAINT AND CAPA MANAGER UPPSALA - SWEDEN
This position is based within Thermo Fisher Scientific's ImmunoDiagnostics Division (IDD), which has its global HQ in Uppsala, Sweden and develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,500 employees worldwide, IDD is the global leader in in-vitro allergy testing and also the European leader in autoimmunity diagnostics.
THE ROLE
As the Complaint and CAPA Manager, you will be joining a group of eight people in the Uppsala office and report into our Director for Global Quality Assurance (QA). It will be your responsibility to ensure that complaints and CAPAs are executed in a timely manner, with patients, customers and safety in focus. This position maintains, develops and measures the complaint processes to ensure compliance.
Key Responsibilities:
• Handling Complaints for IDD globally, including interface to commercial units and distributors
• Member of the Complaint board
• Responsible for providing User training of processes and IT systems
• Overseeing the progression of Complaints and CAPAs
• Establish and monitor KPI/PI for the processes, providing reports to senior management
• Responsible for IDD vigilance handling, managing potential patient and/or user safety situations on the market
• Be an active business partner to the commercial organizations, including the customer service and support teams
WHO ARE WE LOOKING FOR?
To succeed in this role you should have a University degree in medical/technical sciences and at least 5 years work experience in the medical regulated industry. You should have worked with quality management systems in an IVD/Medical device environment (e.g. QSR, EU medical directive, ISO 13485, ISO14971) and have significant experience of problem solving, in investigations and root cause analysis.
The role will suit someone who is driven and has strong leadership, interpersonal and problem solving skills. You must be analytical and should ideally have Lean Six Sigma certification and be able to do process mapping.
You should work with a focus on customers and processes, drive cross-functional collaboration and be good at organising your work.
Excellent verbal/written communication skills in both Swedish and English are required
Thermo Fisher Scientific is an international, matrix organisation so you should be comfortable working cross-functionally, managing a wide range of priorities and working in an ever-changing environment.
IS THIS THE OPPORTUNITY FOR YOU?
At Thermo Fisher Scientific, each one of our 55,000 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. What story will you tell?
If you have questions then please contact Victoria Johansson (Senior Recruiter Nordics)
victoria.johansson@thermofisher.comPubliceringsdatum2017-01-23Så ansöker duSista dag att ansöka är 0001-01-01
Kontaktvictoria.johansson@thermofisher.comFöretagThermo Fisher Scientific
AdressThermo Fisher Scientific
Box 6460
75137 UPPSALA
KontorsadressRapsgatan 7P
Jobbnummer 3277053
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