Are you looking for more than just a job, for something truly meaningful and rewarding? Then Sysmex Europe SE is the place for you. As the regional headquarters for the EMEA (Europe, Middle East and Africa) region, our company is dedicated to providing essential products that help people worldwide on their healthcare journey.
If this opportunity appeals to you, come and join us in the position of
Sysmex provides global healthcare support with diverse medical diagnostics products and solutions. With more than 50 years' experience in in-vitro diagnostics, we improve the patients’ healthcare journey.
Sysmex Europe SE, near Hamburg, Germany, is a regional headquarter for Europe, Africa and the Middle East and serves affiliates, distributors, and customers with over 2,500 employees in the EMEA region, living our mission “Together for a better healthcare journey ” every day.
Team Lead (f/m/x)Quality Management System (QMS)
Norderstedt (near Hamburg)
Lead the activities for the continuity of ISO 13485 certification and maintenance of Quality Management System of the organization
Act as Quality Management Representative and fulfil the relevant responsibilities
Ensure compliance to regulations by providing support for interpretation of standard, performing gap analysis and lead activities to implement improvements when necessary
Ensure that QMS processes are established, implemented and maintained
Provide Quality System Management expertise and support to the organization
Support the implementation and maintenance of the Trackwise as complaint handling and eQMS tool
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
Lead the QMS team through knowledge sharing and coaching of the team for the appropriate application of quality and regulatory requirements
Support the development and implementation of quality related processes and procedures to meet requirements on new standards and regulations, including but not limited to, ISO 13485 and IVDR
Maintains Quality knowledge needed for support in the areas including Processes, Change Control, Customer Complaints, CAPA, Audit, Design and Development, Risk Management, Supplier Controls, Production
Leonie Nolte
jobs@sysmex-europe.com
Reference No.: 09982
Sysmex Europe SE, Bornbarch 1, 22848 Norderstedt
We are an aspiring corporate group where respect and trust form the basis for cooperation and communication within Sysmex.
Did we spark your interest? Then we look forward to receiving your application with salary requirements and the earliest possible starting date.