Quality System Manager Uppsala
Thermo Fisher Scientific / Organisationsutvecklarjobb / Uppsala
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hela Sverige 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 1,600 employees worldwide, IDD is the global leader in in-vitro allergy testing and also the European leader in autoimmunity diagnostics.
THE ROLE
The Quality System Manager will be responsible for implementing and maintain compliance to the Quality Agreements that has been established between the manufacturing site and the commercial organizations. The position will play a key role in supporting the Quality System improvements at the commercial organizations and identifying and implementing necessary interfaces between the organizations.
Responsibilities include:
• Implementing the requirements and maintain compliance to the Quality Agreements that has been established between the manufacturing site and the commercial organizations.
• Assure the Quality System at the manufacturing site is reflective of any specific requirement associated with any of the subsidiaries included in a quality agreement.
• Play a key role in supporting the Quality System improvements at the commercial organizations and identifying and implementing necessary interfaces between the organizations.
• 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).
• Participate in or lead the completion and maintenance of risk analysis related to quality systems.
• Take ownership for specific business processes as assigned.
• Train personnel on Quality Management System related topics.
WHO ARE WE LOOKING FOR?
We are looking for someone with a University degree in medical/technical sciences and several years of work experience in the medical regulated industry.
To succeed in this role 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 analyzing and interpreting regulations, directives and standards.
• Be someone who works analytically and enjoy problem solving.
• Have strong leadership and interpersonal skills, process and customer focused.
• Have experience from working in an international environment, and have interest in understanding and operating within a multi-cultural geographical spread.
• Drive cross-functional collaboration.
• Be able to organize your work and decide about and reach objectives for the processes.
• Be competent in process mapping.
• Speak English and Swedish fluently.
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.com THERMO FISHER SCIENTIFIC
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 18 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.
Publiceringsdatum2017-08-02Så ansöker duSista dag att ansöka är 0001-01-01
FöretagThermo Fisher Scientific
AdressThermo Fisher Scientific
75137 UPPSALA
Jobbnummer 3625105
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