Quality System Manager and Lead Auditor

QUALITY SYSTEM MANAGER AND LEAD AUDITOR
Uppsala, Sweden
HOW WILL YOU MAKE AN IMPACT?
As the Quality System Manager and Lead Auditor, you will be joining a group of six people in the Uppsala office and report into our Manager, Quality Systems. 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 internal and external audits, as well as audit the division’s commercial units.


WHAT WILL YOU DO?
Keep up-to-date, and ensure compliance with, applicable regulations, standards and guidelines
Plan and follow up on the annual audit program, performing these audits according to plan and maintaining and developing the audit process
Perform Supplier Audits and complete requests for Vendor/Supplier questionnaires
Establishing and monitor KPI/PI for the process, providing reports to senior management.
Planning and coordinating inspections conducted by external authorities and customers
Serve as compliance expert in the Quality Management System renewal and adaption of the EU IVD Regulation
Taking ownership for specific business processes as assigned



IS THIS THE ROLE FOR YOU?
To succeed in this role you should have a University degree in medical/technical sciences and work experience in the medical regulated industry. Ideally you have a minimum of 2 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 approximately 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.
You are a solid team player who is good at building relationships with other people and has the ability to work across multiple functions and disciplines.


APPLY NOW on our career site http://jobs.thermofisher.com
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.
If you have any questions, please contact
Sr. Recruiter, Nordics, Nina Albuquerque: nina.albuquerque@thermofisher.com
Or
Manager, Quality Systems, IDD, Mats Norberg: mats.norberg@thermofisher.com
Application deadline 9 March 2020