Work Flexibility: Hybrid or Onsite
As a Senior Quality Engineer (m/w/d) in Post Market Surveillance, you will be responsible for investigating complaints related to the Instruments Navigation portfolio. In this role, you will analyse reported issues, evaluate underlying technical causes, and contribute to the ongoing monitoring of device performance while working in a globally connected and international setting. In addition, you will support quality system activities and continuous improvement efforts within a leading medical device organization.
What You'll Do:
1. Conduct structured investigations of complaints related to navigation issues, concentrating on identifying root causes and utilising software logfile evaluation as part of the overall analysis process.
2. Perform risk assessments and failure mode evaluations as part of the regular scope of work, in collaboration with Quality, R&D, Manufacturing and other functions
3. Initiate and support quality actions resulting from complaint investigation outcomes, as required
4. Support device performance monitoring using data from IT systems such as SAP and Salesforce, including data review and correlation to support issue identification and continuous improvement
5. Participate in operational, cross‑functional projects aimed at the sustainable improvement of products
What You'll Need:
6. You have successfully completed a technical degree in mechanical engineering, medical technology, or materials science, or possess a comparable qualification.
7. You enjoy getting to the root of problems, and your strong analytical thinking combined with your problem-solving skills enable you to carry out well-founded root cause analyses and identify trends.
8. You have a strong affinity for IT and digital tools.
9. You enjoy working and communicating across different interfaces and departments.
10. Experience with the medical device standard ISO 13485 as well as post-market surveillance of medical devices (EU MDR 2017/745) would be a plus.
11. Your profile is rounded off by very good written and spoken English skills and confident use of MS Office.
Travel Percentage: 10%