CK Group is recruiting for a Quality Engineer to join a pharmaceutical company at their site based in Cambridge on a contract basis for 6 months initially.
For the purposes of this specification Combination Product, Medical Device or In Vitro Diagnostic Devices (IVDD) will be referred to as ‘device’
• To work with drug product teams and external design companies in developing device design control documentation, device risk management and human factors engineering documentation and design history files.
• To assist in the generation of regulatory submission documentation for devices.
• Responsible for generation, approval and storage of all device design control documentation and 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 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.
• Support the DCoE device design change control system ensuring that quality and regulatory requirements are satisfied.
• 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.
• Provide support for generation and approval of DCoE equipment qualification documentation.
• 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.
• Support the generation of all regulatory submission data and content for assigned device projects.
• Support internal and external audits of the DCoE Quality System.
• Support the generation of DCoE Cambridge site quality metrics.
• Support all DCoE Cambridge personnel in authorship, where appropriate, and ensuring compliance to policies and procedures.
• Degree, HND or equivalent in relevant subject.
• History of working in accordance with the requirements of ISO 13485, ISO 14971 and 21 CFR 820.
• Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, EN 60601, EN 62304 and the EU Medical Devices Directive.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA42643 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: KA42643
- Updated: 4th July 2018
- Expires: 1st August 2018