Quality Engineer

Job Role:

• To work with drug product teams and external design companies in developing device design control documentation.
• To work with drug product teams and external design companies in developing device risk management and human factors engineering documentation.
• To work with drug product teams and external design companies in developing design history files.
• To assist in the generation of regulatory submission documentation for devices.

Major Duties:

• Responsible for generation, approval and storage of all company device design control documentation for assigned device projects.
• Responsible for generation, approval and storage of all company device risk management documentation for assigned device projects.
• Ensure effective risk management activities at external design companies and all manufacturing facilities related to assigned projects.
• Responsible for generation, approval and storage of all company device manufacturing control strategy documentation for assigned device projects.
• Provide input and support to human factors human factors engineering documentation for assigned device projects.
• Support the assessment of external design companies and suppliers for capability of quality systems, facilities and procedures to support device development and supply
• Provide input to and support completion of external design companies/supplier device design and process risk assessments.
• Provide input to purchase specifications for device assemblies and components.
• Work as part of a multidisciplinary team to determine what performance factors of the drug delivery device are critical to the compliance of the finished product and their implications for assessments and investigations.
• Assist in the application of design control as and when required to other device development projects.
• Ensure effective device design change control, ensuring that quality and regulatory requirements are satisfied. *
• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Support the timely completion of complaints related to technical issues associated with devices used in clinical trials and commercial manufacture.

Education, Skills and Experience:

• Degree, HND or equivalent in a relevant subject.
• History of working in accordance with the requirements of ISO 13485, ISO 14971 and 21 CFR 820. Technical Ability
• Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, EN 60601, EN 62304 and the EU Medical Devices Directive.
• Able to learn and apply established procedures in a reliable and consistent manner.
• Able to travel or relocate to Cambridge area
• Able to travel to within the UK and overseas for work on an as-needed basis.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.