Design Assurance Quality Engineer

at  Merck Group

Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

The Design Assurance Quality Engineer is responsible for maintaining compliance of the IVD and Medical Device product portfolio to the applicable Design Control, Quality and Regulatory standards.

Key Responsibilities:

• Ensure product documentation is maintained in compliance to the latest Design Control procedures, Quality and Regulatory standards
• Support the execution of the Medical Device Regulation project for Class IIa Medical Devices.
• Ensure products are maintained throughout the full product lifecycle, from product launch to post market surveillance in compliance with global standards and latest state of the art requirements.
• Responsible for completing Design Change Assessments for Change Controls impacting regulated products.
• Support the introduction/implementation of product/process/materials changes to the manufacturing operation.
• Ensure that product/process/package/label/Test Method designs and associated documentation comply with applicable Standards and Regulations for products distributed globally.
• Support internal and external audits and regulatory inspections.
• Collaborate with Reg Affairs and Marketing to provide necessary product documentation for Regulatory submissions.
• Maintain Technical Documentation including Standards assessments, Usability, Post-Market Surveillance, Risk Management and Design Verifications.