Engineering Compliance and CSV Manager

Hi! We are AMBOSS, and we're looking for someone to take the role of Engineering Compliance Manager and CSV & Process Validation Manager in our medical device team.

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AMBOSSAMBOSS is a dynamic learning and clinical decision support tool committed to empowering physicians globally to deliver optimal care

Since our inception in 2012, we've harnessed cutting-edge technology to transform the way physicians acquire and apply scientific knowledge.

Each AMBOSSian is passionate about being the champion of clinicians today - this motivates and unites us each day towards success.

And what does success look like? When a clinician or med student tells us, “AMBOSS makes practicing medicine easier and enjoyable.

I love what I do, and a big part is because of AMBOSS.

”Why can this position be exciting for you?At AMBOSS, we build tools that help doctors and students make critical decisions impacting the healthcare of billions of people worldwide.

This position makes sure that our product is built, verified, and documented in a way that's compliant, trustworthy, and audit-ready.

You'll work closely with engineering as an independent evaluator, setting the standard for what "done and compliant" means across our medical device software.

Join a small, high-impact team ensuring our medical device software meets the regulatory standards needed to safely support healthcare professionals.

You will:As CSV & Process Validation Manager, prove our systems and processes work and produce reliable evidence.

• Own the computer system validation and process validation processes for the AMBOSS medical device portfolio — procedures, templates and work instructions — keeping them aligned with MDR and ISO 13485 and updated based on audit findings and team feedback.
• Maintain the inventory of systems in scope and decide, risk-based, which need validation and to what depth; plan, execute and document that validation and keep systems in a validated state as they change.

Concentrate validation effort where.