Quality System Manager And Lead Auditor
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.
QUALITY SYSTEM MANAGER AND LEAD AUDITOR
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 Quality System Manager and Lead Auditor, 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 we are compliant with regulations and standards applicable to the medical device and in vitro diagnostic industries. You will arrange site inspections, conduct external and internal audits, as well as audit the division's commercial units.
Further responsibilities include:
• Keep up-to-date, and ensure compliance with, applicable regulations, guidelines and standards
• Perform Supplier Audits and complete requests for Vendor/Supplier questionnaires
• Plan and follow up on the annual audit program, performing these audits according to plan and maintaining and developing the audit process
• Establishing and monitor KPI/PI for the process, providing reports to senior management.
• Planning and coordinating inspections conducted by external authorities and customers
• Playing a key role as compliance expert in the adaption of ISO 13485:2016
• Taking ownership for specific business processes as assigned
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. Ideally you will be a Certified Quality Management System Auditor (or equivalent) and have a minimum of 3 years experience of conducting Quality audits.
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.
Excellent verbal/written communication skills in both Swedish and English are required and you will be expected to travel 10-15% of the time.
The role will suit someone who enjoys working independently, takes initiative, drives performance and is resourceful.
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 3277050
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