Job Description
About the Role
A global biopharma organisation is growing its Devices Centre of Excellence in Cambridge, UK and is looking for a Quality Engineer (Compliance) to support medical device and drug–device combination product programmes across the product lifecycle from early development through to clinical and commercial supply.
This is a hands-on, collaborative role for someone who enjoys being close to the development teams, keeping work audit-ready, and ensuring design control and risk management activities meet internal and global regulatory standards
Key Responsibilities
You’ll act as a quality SME for device and combination product development, with responsibilities including:
*
Leading design control and risk management activities for assigned programmes, ensuring deliverables are accurate, approved and maintained.
*
Supporting and facilitating risk management with external design and manufacturing partners.
A global biopharma organisation is growing its Devices Centre of Excellence in Cambridge, UK and is looking for a Quality Engineer (Compliance) to support medical device and drug–device combination product programmes across the product lifecycle from early development through to clinical and commercial supply.
This is a hands-on, collaborative role for someone who enjoys being close to the development teams, keeping work audit-ready, and ensuring design control and risk management activities meet internal and global regulatory standards
Key Responsibilities
You’ll act as a quality SME for device and combination product development, with responsibilities including:
*
Leading design control and risk management activities for assigned programmes, ensuring deliverables are accurate, approved and maintained.
*
Supporting and facilitating risk management with external design and manufacturing partners.
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