GLOBAL QUALITY SYSTEM MANAGER
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 Global Quality System Manager will be responsible for ensuring a successful adoption of ISO 13485:2016, developing and maintaining the Quality Management System and providing quality system support to the organization (e.g.commercialized products, new product development, manufacturing, and/or system compliance). To participate in and support during external regulatory audits.
• Lead the adoption of ISO 13485:2016 for the division, including Quality Planning and implementation.
• Lead the Quality Management System harmonization between the division’s sites.
• 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 for external audits and support or participate during external audits.
• Take ownership for specific business processes as assigned.
• Train personnel on Quality Management System related topics.
WHO ARE WE 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.
• Have strong leadership and interpersonal skills, and drive cross-functional collaboration capabilities
• Be someone who works analytically, enjoys problem solving and who is able to drive the work forwards and complete it in the allocated time
• Cross-functional collaboration is key to success in this role.
• Be organised, target driven and good at identifying process objectives and process mapping.
• Speak English and Swedish fluently and have strong communication skills, including cross-functional communication.
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?
APPLY NOW on our career site http://jobs.thermofisher.com
APPLICATION DEADLINE: June 14, 2017
If you have questions then please contact Victoria Johansson (Senior Recruiter Nordics) email@example.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.