Accountable for the timely handling of individual cases (Inquiry, 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 trouble-shooting and resolution of cases.
Resolves cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects.
Assumes 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.
May provide audit and inspection support as requested.
Participate in the on-boarding and mentoring activities of new employees and team members as assigned.
Interface with Affiliates and assumes responsibility for timely communication of quality related information to the Country Organizations. Supports initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.
Responsible for experimental design of complaint investigations, conducts investigation experiments. May partner with internal Roche Global Functions (i.e. Operations, Research and Development, CDMA).
Responsible for escalating cases which cannot be directly resolved to appropriate levels and initiating further investigation and communicates case derived information as appropriate.
May contribute with skills to projects as e.g.SQUADs/community of practises.
May act as a proxy for an Engineer role.
Supports product teams by providing information from cases in order to update product documentation.
The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. May be required to perform other duties as assigned to meet the PMQ goals and objectives as appropriate.
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.
You successfully passed a vocational training in Information Technology or Biomedical Engineering.
Work experience in the area of information technology in either 1st or 2nd level support or R&D related functions.
Strong communication skills in English (written and spoken) are essential.
You are able to read and understand source code in a programming language.
You have a passion for clean and structured code and solid future-proof architectures.
You have in mind testing strategies.
You are able to debug source code of different programming languages to understand the root cause of reported issues.
Knowledge of other database engines is a plus.
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) is a plus.
Knowledge of the diagnostic market is desired.