Quality Engineer (23491)

Are you a talented Design Assurance or Quality Engineer with experience of taking medical products to market? Do you want to be an integral member of multidisciplinary teams, developing innovative medical products?

As a Design Assurance / Quality Engineer, you will make a significant contribution to major medical technology development projects. You will translate regulatory requirements into product requirements for innovative medical products, and ensure compliance to relevant standards and regulations throughout.

Minimum requirements

To meet the requirements of this role, you will have:

• A good degree in Engineering or related technical discipline
• Experience of working in multi-disciplinary teams in at least one of the Division’s four focus areas
• Significant experience of risk management with regard to Medical Product development (according to ISO14971)
• Excellent understanding of medical device directive 93/42/EEC, ISO13485 and FDA QSR
• Experience of Design Verification
• Excellent communication skills
• Ability to review the work of others

The following would also be beneficial:

• Knowledge and experience of implementing IEC 60601
• Knowledge and experience of implementing IEC 62304
• Experience of liaising with the US FDA with regards to device submissions
• Experience of Design Validation

Please note: even if you don't have exactly the background indicated, do contact us now if this type of job is of interest - we may well have similar opportunities that you would be suited to. And of course, we always get your permission before submitting your CV to a company.