- You ensure adherence to Quality Management related processes and procedures, and oversee related operational and/or support activities, e.g., 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.
- 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 (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.
Organization: Siemens Healthineers
Company: FAST TRACK DIAGNOSTICS LUXEMBOURG S.à r.l.
Experience Level: Experienced Professional
Job Type: Full-time