Digital Solutions QA Engineer — ISO & Complaint Expert

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

As an Engineer PMQ you will be dealing with complaints concerning Digital Solutions quality and product performance of Hospital / Laboratory Information Systems (HIS / LIS), medical data networks, middleware solutions. data communication, apps 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 SW malfunction / SW 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 responsabilities :

You will be 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.

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.

Providing audit and inspection support as requested and contributing to the creation of regular reports to document on-market product quality and performance, to escalate critical issues to the responsible Life Cycle Teams and to define pro-active 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.

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 or you successfully passed a vocational training in Information Technology or Biomedical Engineering

You have more than 2 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 & 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 engine & 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)

At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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