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 in the Post-Market Quality area, you support the x800 Community within the Molecular Lab Network with handling customer complaints. You are part of the Global Quality and Regulatory organization at Roche Diagnostics.
The Opportunity
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.
Resolve cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects.
Assume 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.
Assume responsibility for ensuring risk assessments for product quality issues are complete.
Participate in the on-boarding and mentoring activities of new employees and team members, as assigned.
In Case Handling and Affiliate Support (CHAS) - Interface with Affiliates, assuming responsibility for timely communication of quality related information to the Country Organizations. Support initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.
In Complaint Investigation and Resolution (CIR) - Responsible for experimental design of complaint investigations, conducts investigation experiments. Partner with internal Roche Global Functions (i.e. Operations, Research and Development, CDMA).
Ensure cases are compliant and conform to established quality processes, standards, and regulations.
Support product teams by providing information from cases in order to update product documentation.
Contribute 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.
Create “notifications” (bulletins and communications to affiliates and, ultimately, customers via the local organizations), and approve notifications received.
In RIS&SSW: 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.
Who You are
You hold a university degree (Bachelor's/Master's) in a scientific/technical field (e.g. chemistry, biology, or computer science) with several years of professional experience as well as experience in the field of medical diagnostics is required.
Excellent communication skills (English) as well as effective collaboration with cross-functional teams.
A strong team player with excellent interpersonal skills and a customer-oriented mindset.
Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!
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.