Engineering Compliance Manager and CSV & Process Validation Manager
AMBOSSRemotely
reactgopythonawsphpkubernetesterraformargocd
Job Description
📋 Description
- Own CSV and process validation for AMBOSS medical device portfolio
- Ensure MDR/ISO 13485 compliance in procedures and templates
- Manage validation breadth based on risk and system changes
- Provide evidence to auditors/regulators and handle CAPAs
- Oversee software lifecycle compliance from requirements to release
- Collaborate with engineering to implement compliance gates
🎯 Requirements
- Knowledge of MDR, ISO 13485, IEC 62304, IEC 82304-1
- Familiarity with React, Python, PHP, Go; AWS, Terraform, Kubernetes, ArgoCD
- Experience presenting validation docs to auditors/inspectors
- Excellent written and spoken English
🎁 Benefits
- Benefits package supporting financial, physical, and mental health
- Inclusive, supportive work environment
- Encouragement to apply even if not all points are met
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