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Produktspecialist på Midt-og Vestsjælland

Job på Midt-og Vestsjælland

The job:
Are you an experienced Quality Engineer, and do you enjoy working with technical quality engineering? Then you might be the person we are looking for! We are currently looking for a Senior Technical Quality Engineer to join us in this newly created role. The position will be based at our production site in Roskilde, Denmark.

As our new Senior Technical Quality Engineer, you’ll report to our Quality Director based in the US, and you’ll be part of our Quality Operations team, and you will play a critical role in managing system quality (quality system, product quality, and solution quality and risk management) throughout the product life cycle.

What will you do?
• Creation/Update technical documentation (labelling, packaging) according to FDA/ MDR/IVDR, assess changes and update DHF (traceability matrix)
• DHF Remediation and sustaining activities
• Ensures that appropriate quality plans are developed to include all stages of the life cycle of the product and supports Quality Plan design, product specifications, quality specifications and quality plans in conjunction with other product development team members
• Drives the validation of key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the Quality Plan, any ...