Quality Team Lead (M / F / D)
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents.
More than 60,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients.
An estimated 5 million patients across the globe benefit every day 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.
This is what truly matters to us.
Join our team now at Fast Track Diagnostics, a Siemens Healthineers company, in Luxembourg as
Quality Team Lead (M / F / D)
Your tasks and responsibilities :
You ensure adherence to Quality Management related processes and procedures, and oversee related operational and / or support activities, , non-conformance and CAPA process, internal / external audits, document and change control, training, and outsourced processes
You lead an assigned quality team. You prioritize and assign tasks to team members and check progress of agreed transactions and workflows
You ensure that employees understand the consequences of not meeting customer and regulatory requirements
You manage quality-related activities with internal and external parties involved
You analyze and improve 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.
You drive Digitalization of quality processes
You implement the specific quality programs within your organization and monitor the effectiveness of these programs
You contribute to product safety activities
You ensure real-time quality reporting for ad-hoc analysis, instant decision making, preventive action and continuous improvement
You contribute to budget planning processes
You ensure qualification and competences of the assigned team
You act as an escalation point of contact for quality issues
You ensure the quality reporting.
Your profile :
MSc or BSc in a technical field (scientific or engineering background preferred) or equivalent combination of education and experience;
3-5 years of professional experience in in-vitro medical device industry;
Expert knowledge of quality standards and requirements ( , ISO 13485 : 2016, QSR, IVDD, IVDR) is required;
Experience with managing external inspections, , 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.
Convinced by our company culture, purpose, and responsibilities? Apply now, we are already looking forward to getting to know you! If this position isn’t what you are looking for, but you want to be considered for future needs, don’t hesitate to upload your resume in our Talent Community.
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