Quality Engineer

BioTalent • Cambridgeshire, ENG, United Kingdom • 22h ago

Job Description

Job Description

To provide design control and risk management support to combination product/medical device development programmes. This will chiefly involve the generation and review of documentation required for design history files. Other responsibilities will include facilitation and documentation of risk management activities associated with combination products/medical devices. The role is based in Cambridge; however, project teams are global in nature.

Position Responsibilities

Generation, approval and retention of device design control and risk management documentation ensuring that quality and regulatory requirements are satisfied.

Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.

Provide input and support to human factors engineering documentation.

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 System.

Education, Skills & Experience

Degree, HND or equivalent in relevant subject.

History of working in accordance with the requirements of ISO 13485, ISO 14971 and 21 CFR 820.

Technical Skills & Requirements

Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820 and the EU Medical Devices Directive.

Working knowledge of EN 62366, EN 60601, EN 62304 and EU Medical Devices Regulation.

Able to learn and apply established procedures in a reliable and consistent manner.