Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?
Then come and join our global team as
Quality Management scientist
Your tasks and responsibilities:
• Confirmation of complaints: Ensure proper receiving, reviewing, analyzing, and processing of product complaints for manufactured and distributed products.
• Ensure escalation to CAPA and Risk Management processes and trending of complaints according to internal processes.
• Monitor, detect, and assess quality and safety issues associated with distributed product: ensure that complaints are assessed for safety reporting and, if necessary, initiate communication with National Competent Authorities within the applicable reporting deadlines (Adverse Event, Field Safety Notice). Implement Customer/Field Safety Corrective Action.
• Work tightly with Siemens customer center staff to ensure good communication of customer feedback.
• Write and review relevant documentation.
• Review and approve documentation for compliance with EU, and other international regulations
• Identify and manage areas of potential noncompliance (Process quality deviations CAPAS)
• Monitoring and further development of the QM System according to ISO 13485 and regulatory requirements in accordance with the IVD guidelines.
• Work as a member in the quality department.
Your qualifications and experience:
• Minimum BA/BS in scientific field such as molecular biology, microbiology, or a related field.
• Good understanding and knowledge of ISO 13485:2016, ISO 14971, IVDD 98/79/CE, Canadian regulations, FDA regulations, (other regulations would be considered as a plus).
• Experience in RT-PCR is an asset.
Your attributes and skills:
• You are a driven individual with a history of developing collaborative, cross-functional solutions
• You have highly developed writing and interpersonal skills with the ability to work on diverse teams
• You have a professional working knowledge of common software packages (Word, PowerPoint, Excel)
• You have excellent written and spoken English language skills
• You have capacity for working independently and excellent interpersonal and organizational skills.
Our global team:
Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. 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.
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
Organization: Siemens Healthineers
Company: FAST TRACK DIAGNOSTICS LUXEMBOURG S.à r.l.
Experience Level: Experienced Professional
Job Type: Full-time