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The Position As a Principal Software Engineer PMQ, you will be dealing with complaints concerning Digital Solutions quality & performance of Hospital/Laboratory Information Systems (HIS/LIS), medical data networks, middleware solutions, data communication, apps, and algorithms.
As a member of the Digital Solutions Chapter, you will be working in a very transversal Software environment having the opportunity to work with cutting-edge technologies and different programming languages for on-premise and cloud-based software.
You need to be able to read and understand source code in order to find out the root cause/causal factor of a software malfunction/issue, and also be able to learn about Software requirements, fixing bugs process (even if you will not fix them) and general code maintenance, all of it in an Agile environment where you could contribute with your own ideas and proposals in a team continuously improving.
Your main responsibilities: Being accountable for the timely handling of individual cases (Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements and regulations, and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site troubleshooting, and resolution of cases.
Resolving cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects assuming responsibility to ensure, by collaborating and interfacing with the BA and global and/or local functions, appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner.
Contributing to the creation of regular reports for PMQ or project teams as required, as well as to document on-market product quality and performance, to escalate critical issues to the responsible Life Cycle Teams and to define proactive measures.
Supporting regular review of quality of case handling and analyze feedback on customer satisfaction to permanently optimize processes to increase quality and efficiency standards with a focus on customer, compliance, and continuous improvement.
Assuming responsibility to ensure risk assessments for product quality issues are complete & being responsible for experimental design of complaint investigations, conducting investigation experiments analyzing data using statistical measures for determining a potential product performance issue.
Who you are: You own a Graduate Degree from a University for Information Technology (IT) or Biomedical Engineering or from a Professional Education and Training College (Higher Technical School) or equivalent professional experience AND you successfully passed a vocational training in Information Technology or Biomedical Engineering.
You have more than 6 years of work experience in the area of information technology in either 1st or 2nd level support or R&D related functions.
You have strong communication skills in English (written and spoken).
You are able to read and understand source code in a programming language and you have a passion for clean and structured code and solid future-proof architectures having in mind testing strategies.
You are able to debug source code of different programming languages to understand the root cause of reported issues.
Would be a plus: Knowledge of other database engines & Knowledge of IVD regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485).
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