Qa Device Manager

• Set direction for device quality and compliance in development projects in line with ISO 13485 and QMSR requirements
• Provide timely QA guidance to device and combination product activities supporting investigational programs
• Collaborate closely with Zealand’s device development organization and external device partners/suppliers to ensure compliant execution
• Develop, maintain, and improve device and combination product QMS documentation (e.g., SOPs and related controlled documents)
• Support inspection readiness and partner audit preparation, and drive continuous improvement and simplification of quality processes

• Master’s degree in life science, engineering, pharmaceutical sciences, or similar
• Several years of experience with medical devices and/or combination products in the pharmaceutical or medical device industry
• Solid working knowledge of ISO 13485 and quality system requirements
• familiarity with QMSR is required
• Experience from Quality Assurance in device development settings
• Strong stakeholder management skills and ability to collaborate in an outsourced setup with suppliers and partners
• Excellent written and verbal communication skills, with a structured and solution-oriented approach

GMP knowledge is considered a plus, but is not required