QA Automation Engineer

• Industrial IT/automation project management in cross-functional development projects in various stages from concept to commissioning and handover
• Design, risk and requirements handling as well as testing and validation of control systems for production of Medical Device products
• Develop documentation in compliance with our quality management system built on regulatory requirements from the European medical device directive and FDA quality systems regulations
• Integration of machine line and components with a systems perspective on process control, traceability and communication with MES/SCADA and PDM systems
• Contribute in Wellspect’s digitization development strategy e.g. collection of data for analysis and application development
• Establish and maintain good working relationships with our internal suppliers and stakeholders as well as our external suppliers, also including evaluations and supplier visits

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