Huidige banen gerelateerd aan Quality Assurance Manager Design Controls - Utrecht, Utrecht - Panda International
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Regulatory Compliance Manager
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Regulatory Compliance Specialist
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Utrecht, Utrecht, Nederland Panda International VoltijdKey ResponsibilitiesThe Regulatory Compliance Specialist will be responsible for:Oversight of design control activities, ensuring compliance with ISO 13485, MDR, PPE, and ISO 14971 risk management standardsManagement of design history files, supervision of product testing, and EU regulatory complianceLeadership of quality assurance initiatives, mentorship...
Quality Assurance Manager Design Controls
7 dagen geleden
As a QA Manager with Panda International, you will oversee design control activities, ensuring compliance with ISO 13485, MDR 2017/745, PPE, and other applicable regulations. This role requires leadership skills to drive quality assurance initiatives, mentor a QA team, and develop process improvements to enhance efficiency and compliance.
About the Role:
You will lead quality assurance initiatives, manage design history files, ensure robust documentation, and supervise product testing. Additionally, you will develop and track quality metrics, report to senior management, and collaborate with Regulatory Affairs on EU requirements.
Key Responsibilities:
- Oversee design control activities
- Ensure compliance with regulatory standards
- Manage design history files
- Supervise product testing
- Develop and track quality metrics
