Quality Engineer - 12 months contract - Cambridge (Hybrid with 2-3 days onsite per week) - upto £21.62 PAYE and £24 per hour Umbrella
Responsibilities:
• Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
• Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
• Provide input and support to design validation including, but not limited to, human factors engineering assessments.
• Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Support the generation of all regulatory submission data and content for assigned device projects.
• Support internal and external audits of the DCoE Quality Management System.
Education and Experience:
Technical Skill requirements: