Complaint Handling and Post Market Surveillance
il y a 7 jours
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**
**Complaint Handling and Post Market Surveillance Professional (M/F/d)**
**Fixed term contract**
**Your tasks and responsibilities**:
Complaint Handling:
- Confirmation of complaints: Ensure proper receiving, reviewing, and processing product complaints for manufactured and distributed products to detect possible quality and safety issues (e.g., adverse events, product malfunctions)
- Ensure escalation of complaints, their assessment for safety reporting and, if necessary, escalation according to Siemens Healthineers (SHS) internal procedures and regulatory requirements within the applicable reporting deadlines.
- Managing complaint trending.
- Initiating and leading meetings to address identified quality and safety issues and manage Field Actions.
Post Market Surveillance:
- Plan and consolidate information for Post Market Surveillance reporting according to SHS internal processes and regulatory requirements (i. e. IVDR)
Other tasks:
- 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.
- Work as a member in the quality management department.
- Write and review relevant documentation.
**Your qualifications and experience**:
- Minimum BA/BS in scientific field such as molecular biology, microbiology, or a related field.
- Experience in life sciences industry
- 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. 66,000 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:_**
- 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._
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