Complaint & Capa Manager
Thermo Fisher Scientific / Kemiingenjörsjobb / Uppsala
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hela Sverige Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit
www.thermoscientific.com/phadiaCOMPLAINT & CAPA MANAGER
Reports To: Director, Global Quality Assurance & Environmental Management (QA& EM)
Position Location: Uppsala, Sweden
Number of Direct Reports: 0
Position Summary:
As Complaint and CAPA manager you are responsible for ensuring that complaints and CAPAs are executed in a timely manner, with patient, customer and safety in focus. This position maintains, develops and measures complaint and CAPA processes to ensure compliance. The position reports to the Director Global QA & EM.
Key Responsibilities:
• Responsible (conduct, develop and measure) for the Complaint handling and CAPA processes in IDD globally, including interface to commercial units and distributors
• Chairman of the complaint and CAPA boards
• Responsible to provide User training for processes and IT systems used
• Overseeing the progression of Complaint and CAPA action plans
• Establish and monitor KPI/PI for the processes, providing reports to senior management
• Member of the maintenance group for PCM (The IT system for CAPA and complaint handling)
• 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
Requirements/Qualifications:
• University degree in medical/technical sciences
• Minimum of 5 years in a medical regulated industry
• Experience from quality and environmental management systems in an IVD/Medical device environment, e.g. QSR, EU medical directive, ISO 13485, ISO14001, ISO14971, etc.
• Significant experience in problem solving, in investigations and root cause analysis
• Excellent verbal/written communication skills; fluent in Swedish and English
Personal skills:
• 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
• Competency in process mapping, Lean Six Sigma certified being an advantage
• Strong analytical problem solving skills
• Strong ability to drive tasks/projects to closure in a timely fashion
For further information please contact:
Kristina Berglund, Global QA & EM +46 18 16 38 90
Annika Berg, Vice President, Global QA, RA & EM +46 18 16 65 51
Hanna Hardenborg, Manager HR +46 18 16 34 45.
Publiceringsdatum2015-02-13Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast månads- vecko- eller timlön
Så ansöker duPlease send your application with CV and marked reference no. 20 to
hr.idd@thermofisher.com no later than March 1, 2015.
Ansökan kan skickas till e-postadress:
hr.idd@thermofisher.comFöretagThermo Fisher Scientific
AdressThermo Fisher Scientific
Box 6460
75137 UPPSALA
KontorsadressRapsgatan 7P
Övriga kontaktuppgifterTelefonnummer: 018-165000
E-postadress:
hr.idd@thermofisher.com Jobbnummer 2165880
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