Post Market Quality Engineer | Engineer/Scientist PMQ
Roche Diagnostics GmbH
Job Summary
As a Post Market Quality Engineer at Roche Diagnostics, you will play a critical role in ensuring the safety and performance of high-end diagnostic systems, specifically the LightCycler family. Your day-to-day responsibilities involve managing global customer complaints, conducting root cause analysis for hardware and software issues, and performing risk assessments in compliance with ISO quality standards. You will act as a bridge between technical teams and patient safety, collaborating with global stakeholders to resolve complex technical challenges and implement corrective actions (CAPA). This position is ideal for a detail-oriented professional with a background in biomedical engineering or IT who thrives in an agile, international environment. You will be instrumental in maintaining Roche's 'license to operate' by providing expert technical support, mentoring team members, and contributing to the continuous improvement of diagnostic solutions that impact millions of patients worldwide.
Required Skills
Education
Bachelor's degree in Information Technology, Computer Science, Biomedical Engineering, or a related field.
Experience
- Professional experience in technical support, preferably within the medical device or healthcare industry.
- Demonstrated experience with NAP/qPCR technologies.
- Experience in complaint handling and quality management systems.
- Experience in managing complex technical investigations and cross-functional project collaboration.
Languages
Additional
- Proficiency in Smarteeva complaint management system is preferred. Knowledge of medical device regulatory requirements is desired.
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