At Fast Track Diagnostics - A Siemens Healthineers Company, our purpose is to enable healthcare providers to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, and improving patient experience, all enabled by digitalizing healthcare.

　　An estimated five million patients globally everyday benefit from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

　　We are a leading medical technology company with over 170 years of experience and 18,000 patents globally. With about 69,000 dedicated colleagues in over 70 countries, we will continue to innovate and shape the future of healthcare.

　　As part of the development of its activities, Fast Track Diagnostics - A Siemens Healthineers Company is looking for a Team Leader, Quality

　　The challenge:

　　As Team leader:

　　Ensures adherence to Quality Management related processes and procedures, and oversees related operational and/or support activities, e.g., non-conformance andCAPA process, internal/external audits, document and change control, training, and outsourced processes.

　　Leads an assigned quality team. Prioritizes and assigns tasks to team members and checks progress of agreed transactions and workflows.

　　Ensures that employees understand the consequences of not meeting customer and regulatory requirements.

　　Manages quality-related activities with internal and external parties involved.

　　Analyzes and improves a series of process steps for the respective organizational unit according to the quality strategy and respective local regulations considering agile, lean and digital methods.

　　Drives Digitalization of quality processes.

　　Implements the specific quality programs within his/her organization and monitors the effectiveness of these programs.

　　Contributes to product safety activities.

　　Ensures real-time quality reporting for ad-hoc analysis, instant decision making, preventive action and continuous improvement.

　　Contributes to budget planning processes.

　　Ensures qualification and competences of the assigned team.

　　Acts as an escalation point of contact for quality issues.

　　Ensures quality reporting.

　　Additional Responsibilities:

　　The employee shall be engaged to familiarize her-/himself with and to adhere to any quality documents relevant for her/his area of activity.

　　To constantly improve the efficiency of the existing quality management system the employee shall be responsible to claim any error and to undertake appropriate corrective actions in accordance with her/his supervisor.

　　On her/his own initiative the employee develops preventive measures and/or suggestions to improve the workflow.

　　Assess, analyze and assist with resolution of quality deviations and CAPAs.

　　Perform product releases and provide support for troubleshooting activities.

　　Perform incoming, in-process and end-of-line inspections.

　　Support production process controls. Support label release activities

　　The candidate requirements:

　　MSc or BSc in a technical field (scientific or engineering background preferred) or equivalent combination of education and experience.

　　5 years of professional experience in in-vitro medical device industry.

　　Expert knowledge of quality standards and requirements (e.g., ISO 13485:2016, QSR, IVDD, IVDR) is required.

　　Experience with managing external inspections, e.g., Notified Bodies, National Competent Authorities.

　　Working knowledge of Medical Device Singe Audit Program (MDSAP) preferred.

　　Excellent communication and organizational skills.

　　Self-motivated leader with a history of developing collaborative, cross-functional solutions. Ability to motivate, engage and inspire the team.

　　Excellent written and spoken English language skill; knowledge of, French, German or Luxembourgish is an asset.

　　GDPR

　　We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.

　　Diversity and Inclusion

　　Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, gender, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, and other categories protected by federal, state or local law.