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Software Quality Specialist - Medtech
TechFirm Engineering · Basel
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Job description
About the Company
At Techfirm, together with our sister company Lucid Analytics, we help organizations turn data into tangible business and operational value through data science, analytics, artificial intelligence, and strong engineering practices. We work in complex technical environments where data is not only used for reporting, but also for supervision, reliability, incident analysis, compliance, and continuous improvement. We believe that good platforms should make systems easier to understand, easier to operate, and easier to improve. Observability is not just about dashboards; it is about building the visibility needed to make better technical decisions.
About the Role
You have experience in software quality, regulatory affairs, verification and validation, or a similar field within a regulated technical environment in MEDICAL DEVICES.
Ideally, you bring:
A strong understanding of software quality and regulatory requirements
Experience with verification and validation, risk management, traceability, and quality documentation
Knowledge of frameworks such as MDR, FDA, EU AI Act, IEC 62304, ISO 13485, or similar standards
The ability to translate regulatory requirements into practical workflows for engineering teams
Confidence in audit and certification contexts, including discussions with auditors, notified bodies, or certification authorities
A pragmatic mindset, with the ability to apply rigor where it matters without creating unnecessary bureaucracy
A good understanding of how software is developed; previous hands-on software engineering experience is a strong advantage
Strong communication skills and the ability to work closely with R&D, engineering, quality, and regulatory stakeholders
A builder mentality, seeing compliance as an enabler for scalable, manageable, and risk-mitigated software development
Qualifications
Engineering background with strong experience in Software quality and regulatory affairs within medical device industry.
Willing to work in Basel
English fluent.
German an asset
We are committed to diversity and inclusivity.
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