Role Summary
We are seeking a skilled Device Development and Manufacturing Operations Specialist to support our device development programs throughout the design and development lifecycle. As a key member of our team, you will ensure compliance with design control requirements outlined in our Quality Management System and relevant Regulations.
Key Responsibilities:
* Establish and maintain Design History Files
* Collaborate with affiliated sites and third parties
* Assess compliance with design control requirements
* Support Risk Management activities through the implementation of ISO 14971:2019
Requirements:
* Bachelor's or Master's degree in engineering or science/life science
* Industry experience in medical devices or pharmaceuticals
* Direct experience of device development and manufacturing operations activities in a GMP environment
Desirable Skills:
* Device development and manufacturing operations
* GMP and quality management systems
* Design control and risk management
* Collaboration and communication
What You'll Need to Succeed:
* 5-7 years at similar level or 5-10 years general experience in industry
* Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment
We offer a dynamic and challenging work environment that values collaboration, innovation, and continuous improvement. If you have a passion for device development and manufacturing operations, we encourage you to apply for this exciting opportunity.