Senior Engineer PMQ

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 a Senior 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 and 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

Main tasks:

• 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.

• May contribute 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.

• May support 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.

• Assumes responsibility to ensure risk assessments for product quality issues are complete.

• 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).

• Analyzes data using statistical measures for determining a potential product performance issue.

• Responsible for escalating cases which cannot be directly resolved to appropriate levels and initiating further investigation and communicates case derived information as appropriate.

• May initiate complaint CAPAs and/or nonconformities and perform any assigned CAPA tasks.

• Assumes responsibility for timely communication of quality related information to the Country Organizations.

• Proficiency in English (B-level), expressed communication skills and intercultural competence.

• May represent the PMQ on cross team meetings and projects.

• Ensures cases are compliant and conform to established quality processes, standards, and regulations.

• Supports product teams by providing information from cases in order to update product documentation.

• Contributes to initial and continuous knowledge transfer from manufacturer, R&D or GCS for new products in the project phase to ensure availability of comprehensive system knowledge.

• Creates “notifications” (Bulletins and communications to affiliates and ultimately customers via the local organizations), approves notifications received.

• May browse the code repository and consult source code files when required to ensure a correct investigation but never making any modifications in the repository or the checked-in source code.

• May act as a coach for colleagues with less experience and provides guidance and feedback to other case owners on the case handling processes and product technical knowledge.

• May lead or contribute with skills to projects as e.g.SQUADs/community of practises.

• May act as a proxy for the Principal role.

• Works autonomously with minimal supervision.

Requirements:

• You have 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

• 2+ years of related experience with thorough technical knowledge

Apply if you are:

• Looking for an opportunity to continue growing in your career while mixing both the technical (IT) and medical fields.

• Quick technology learner.

• A team player who truly believes that together we can go further.

• Not afraid to fail and learn.

• Comfort with uncertainty.

• Looking for a purpose where your work will have a real impact on patient lives. Your work is meaningful to you.

• Passionate and naturally curious.

• Looking for solving real-world problems and helping people.

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 rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.  

Our success is built on innovation, curiosity and diversity. With more than 100 digital technology and data initiatives already underway, Roche is working with innovative companies in the data, analytics and software fields to transform healthcare delivery through digital solutions. Moreover, Roche is one of the highest spender on research and development (R&D) among global pharmaceuticals, spending more than 20% of revenue. This substantial investment has resulted in products that have advanced the understanding of disease and transformed the practice of medicine. 

At the same time, sustainability is an integral part of Roche’s business. We are committed to mitigate environmental impact and climate change, proactively seeking new, more sustainable technologies to achieve this goal. For the eleventh time, Roche has been recognized as the most sustainable company in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI). 

We recognize the importance of work-life balance and personal well-being, considering flexible working options, including remote working, and respecting personal downtime for all roles. We strive to provide our employees with the best possible work environment. For many years, Roche has been consistently ranked as a great place to work by its employees and by external institutions. Furthermore, we are proud to be an equal opportunity employer, offering extensive training and development opportunities that enable all people to bring their unique selves to Roche. 

At the Digital Solutions Post Market Quality department, you will learn about software solutions, as well as varied regulatory requirements and quality practices in the area of medical technology. In this challenging department, you will have freedom for innovation and creativity. In addition, you will have autonomy and flexibility in how to approach your day-to-day tasks, mentored and guided by more senior members of the team. At Digital Solutions, we strive for an agile mindset in our daily work, focusing on achieving the best for patients and continuously working on improving our solutions. Working for Roche means more than just having a job. Guided by integrity, courage and passion, working for Roche means innovating diagnostics, shaping healthcare and changing lives. 

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.