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

Our Company

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)

Location

Norderstedt (near Hamburg)

Your responsibilities

• 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

Do you have questions?

Leonie Nolte
jobs@sysmex-europe.com
Reference No.: 09982

Sysmex Europe SE, Bornbarch 1, 22848 Norderstedt

Your profile

• Successfully completed education or degree in medical technology or biotechnology alternatively, equivalent professional experience
• Profound knowledge of ISO 13485, ISO 19011, IVDR
• Proven experience of ISO 13485 or other standards implementation
• Good communication skills and the ability to make decisions in a consistent and professional manner
• Excellent command of written and spoken English

Our benefits

We are an aspiring corporate group where respect and trust form the basis for cooperation and communication within Sysmex.

• Culture & cooperation
  An appreciative work environment, open corporate culture, flat hierarchies and an inclusive and caring atmosphere. Working in an innovative and international environmentwith a broad learning and development landscape in our EMEA Campus, after-work events for internal networking
• Work-life balance
  Flexible working through flextime and a hybrid working model (60% mobile working, 40% on-site), 30 days annual leave
• Additional benefits
  Christmas and holiday bonuses, childcare allowance, capital-forming benefits, subsidy for company pension scheme, corporate benefits, relocation assistance, subsidised lunch in our canteen
• Health & wellbeing
  In-house gym, various sports courses, massages, company medical and psychological care, workplace glasses, general health management
• Mobility
  Subsidy for the public transport “Deutschlandticket”, free parking, bike leasing via JobRad
• Social Responsibility
  Various opportunities to get involved in different sustainability and charity initiatives, climate friendly and respectful use of resources

Did we spark your interest? Then we look forward to receiving your application with salary requirements and the earliest possible starting date.