Quality System Manager

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?
Our ImmunoDiagnostics Division (IDD) is looking for a Quality Systems Manager, based in Uppsala. This role takes active part in assuring adaption of new or revised Quality System Standards and Regulations, developing and maintaining the compliance and effectiveness of the Quality Management System.
This role also provides quality system support for the organization (e.g. commercialized products, new product development, manufacturing, and/or system compliance), and actively participates in preparing and managing external regulatory audits.
What will you do?
You will take an active part in the adaption of new or revised Quality System Standards and Regulations for the division including Quality Planning and implementation.
You will take an active part in the Quality Management System harmonization between sites within the division.
Provide Quality System expertise to the organization and ensure compliance to ISO 13485, QSR and other applicable Quality System Regulations by supporting interpretation of regulations, performing gap analysis and lead activities to implement improvements.
Investigate 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.
Prepare, support and participate during external audits.
Taking ownership for specific business processes as assigned.
Train staff in Quality Management System related topics.

What will you need?
A university degree in medical/technical sciences and/or significant experience from Quality Management Systems in an IVD/Medical device environment, e.g. QSR, EU medical device directive, ISO 13485, etc.
Strong leadership and facilitator capabilities, being 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
Strong analytical problem-solving skills
Strong ability to drive tasks/projects to closure in a timely fashion
Excellent verbal/written communication skills in Swedish and English
A solid team player who is good at building relationships with other people and have the ability to work across multiple functions and disciplines.

We will review applications on an ongoing basis in order to start the interview and hiring process as soon as possible, so please do not hesitate in making your application.
Apply today! http://jobs.thermofisher.com , ref. 199582BR.
APPLICATION DEADLINE: 24th of April
If you have questions then please contact Mats Norberg, Manager, Quality Systems, tel. +46 72 467 7288, or Petra Norrman, Recruiter Nordics, petra.norrman@thermofisher.com.
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