Quality Engineer

Date Posted: 12/6/2017 Reference: VAC-1004285 Salary: £0 Location: CHESHAM Job type: Permanent Sector: Science | Speciality: Medical Devices Contact: Kieran Whittaker

The Client

My client, based in Buckinghamshire, are pioneers in molecular imaging technologies working on a proprietary product to be used in the detection of cancerous cells during operations, providing real time visualisation of cancerous tissue.

The aim is to improve the quality and success ratings of operations and prevent the need for follow-up operations.

The Role

Working as a Quality Engineer your responsibilities will include:

• Day to day management of Engineering Change and Document Change processes, including involvement in or leading risk assessment, engineering assessment, operations assessment and regulatory assessment for Engineering Changes.
• Supply chain quality management; ensuring that all key suppliers are assessed before commencement of supply and, where necessary, carrying out audits prior to use and on a regular ongoing basis to safeguard the quality of purchased materials. Engaging with suppliers in the event of nonconformity to ensure that a thorough investigation, root cause analysis and corrective actions are implemented by the supplier.
• Managing the CAPA process within the business to ensure that non-conformities are documented, investigated and appropriate action is implemented to prevent recurrence.
• Carrying out internal audits and help to identify and implement improvements to the QMS.
• Management of the Technical Files ensuring that they contain the current version of all documents and archived versions are appropriately controlled.
• Act as management representative and hold annual quality review meetings for the management team

The Candidate

• Medical Device industry experience, preferably in electro-mechanical devices with software.
• At least 3 years’ experience of working within an ISO 13485 QMS compliant environment.
• Competent at all CAPA methodologies.
• Preferably qualified ISO 13485 Internal Auditor with experience, Lead Auditor qualified would be highly desirable.
• Excellent interpersonal and effective communication skills at all levels.
• Highly confident Microsoft Office user skills.
• Self-managing, resilient and pragmatic..

Salary is negotiable on experience


This is an opportunity to join a true pioneer in the medical imaging industry who work to improve the quality and success of cancer operations.

For more information and a confidential discussion, please contact Kieran Whittaker on the below: -

Tel: 0161 923 8174
Email: Kieran.Whittaker@wearenorthpoint.com