Quality Engineer - Medical Devices

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Job description

TEC Partners are pleased to be working with a well-funded point of care diagnostics business who are addressing how molecular diagnostics will have an impact on how infectious disease are managed at a point of care.

Quality Engineer Role:

The Quality Engineer is responsible for ensuring quality managements are incorporated into the product from concept, design and development to manufacturer. The position provides engineering leadership to the development and design teams. There is a strong focus on product risk management as well as the creation and maintenance of the product design history file.

Quality Engineer Responsibilities:

Lead product risk management activities in line with ISO 14971
Provide oversight of hazard analysis, FMEA's and FTA's
Fulfil the active role of quality representative at design authority and review meetings
Create and maintain history file / technical design dossier
Assess technical design and update regulatory authorities when necessary

Quality Engineer Requirements:

Minimum of 5 years in the medical device industry including IVD design
Engineering degree in a relevant discipline or equivalent experience
Experience working within a regulatory framework (ISO 13485)
Proven experience providing quality oversight in design review meetings
Able to apply core quality tools and methodologies such as: 8D DMAIC

Quality Engineer Desirables:

Experience bringing medical devices to market in the US and other markets
Experience of cGMP including QC and manufacturing line validation activities
Trained ISO 13485 internal auditor

In return, you'll receive an attractive salary and benefits package, which includes generous holiday allowance, excellent company pension, bonus and private health care.

If you possess the skills and experience required, submit a copy of your CV straight away to be considered